Device Desk

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FDA device establishment · Midvale, UT

This page shows the yearly renewal for this site, from FDA’s public record.

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Renewal dossierDD-3031571797As of September 30, 2026

ENABLECV, LLC

Registration 3031571797FEI 3031571797Midvale, UT

Owner/operator: enableCV, LLC

  • Develop Specifications But Do Not Manufacture At This Facility

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
55
Added, last 12 months
53

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 55

CodeDeviceClassRegulationPremarket
DTLCardioplegia delivery monitoring and infusion setsAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassAdded Mar 31, 2026Class 221 CFR 870.4290K892377
DTLCardioplegia Delivery SetsAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassAdded Mar 31, 2026Class 221 CFR 870.4290K113667
DQROptiSite Arterial CannulaCannula, CatheterAdded Jan 15, 2026Class 221 CFR 870.1300K073559
DQRInternal Mammary Artery CannulaeCannula, CatheterAdded Mar 31, 2026Class 221 CFR 870.1300K960098
DQRArterial Perfusion CannulaeCannula, CatheterAdded Mar 31, 2026Class 221 CFR 870.1300K894243
DWFPercutaneous Insertion Kit (PIKA5 - Arterial, PIKV5 - Venous)Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassAdded Dec 18, 2025Class 221 CFR 870.4210K123303
DWFEndoReturn Arterial CannulaeCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassAdded Jan 15, 2026Class 221 CFR 870.4210K971291
DWFEmbol-X arterial cannulaeCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassAdded Mar 31, 2026Class 221 CFR 870.4210K102420
DWFThruport Endodirect Arterial CannulaCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassAdded Mar 31, 2026Class 221 CFR 870.4210K093730
DWFThruport Endodirect Arterial CannulaCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassAdded Mar 31, 2026Class 221 CFR 870.4210K994243
DWFVascushunt carotid shuntsCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassAdded Mar 31, 2026Class 221 CFR 870.4210K860497
DWFAortic Perfusion Cannulae; Pediatric Peripheral access arterial cannulaCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassAdded Mar 31, 2026Class 221 CFR 870.4210K033463

and 43 more on your full dossier

What changed

  • Mar 31, 2026Listing added: DTL — Cardioplegia delivery monitoring and infusion sets (K892377)
  • Mar 31, 2026Listing added: DTL — Cardioplegia Delivery Sets (K113667)
  • Jan 15, 2026Listing added: DQR — OptiSite Arterial Cannula (K073559)
  • Mar 31, 2026Listing added: DQR — Internal Mammary Artery Cannulae (K960098)
  • Mar 31, 2026Listing added: DQR — Arterial Perfusion Cannulae (K894243)
  • Dec 18, 2025Listing added: DWF — Percutaneous Insertion Kit (PIKA5 - Arterial, PIKV5 - Venous) (K123303)
  • Jan 15, 2026Listing added: DWF — EndoReturn Arterial Cannulae (K971291)
  • Mar 31, 2026Listing added: DWF — Embol-X arterial cannulae (K102420)
  • Mar 31, 2026Listing added: DWF — Thruport Endodirect Arterial Cannula (K093730)
  • Mar 31, 2026Listing added: DWF — Thruport Endodirect Arterial Cannula (K994243)
  • Mar 31, 2026Listing added: DWF — Vascushunt carotid shunts (K860497)
  • Mar 31, 2026Listing added: DWF — Aortic Perfusion Cannulae; Pediatric Peripheral access arterial cannula (K033463)
  • Dec 11, 2025Listing added: DWF — FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA (K123298)
  • Jan 15, 2026Listing added: DWF — Retrograde Cardioplegia Catheters (K123187)
  • Jan 30, 2026Listing added: DWF — Single Stage Venous Drainage Cannula (K120072)
  • Jan 15, 2026Listing added: DWF — Arterial Cannula Families (EZ Glide, OptiSite and EndoReturn) (K233895)
  • Mar 31, 2026Listing added: DWF — Cardioplegia Kits (K901231)
  • Mar 31, 2026Listing added: DWF — Vasoplegia cannulae (K896778)
  • Mar 31, 2026Listing added: DWF — Duraflo-treated femoral cannulae (K905312)
  • Mar 31, 2026Listing added: DWF — Vent Catheters (K113411)
  • Mar 31, 2026Listing added: DWF — Porous Vent plugs (K861322)
  • Mar 31, 2026Listing added: DWF — Pressure monitoring extension lines (K896777)
  • Mar 31, 2026Listing added: DWF — Carotid shunts (K861790)
  • Mar 31, 2026Listing added: DWF — Thruport Endovent Pulmonary Catheters (K981009)
  • Mar 31, 2026Listing added: DWF — Tapered carotid bypass shunts (K860988)
  • Mar 31, 2026Listing added: DWF — Axillary Access Arterial Cannulae (K002578)
  • Mar 31, 2026Listing added: DWF — Antegrade Cardioplegia Cannula (K113459)
  • Jan 15, 2026Listing added: DWF — Femoral Access Arterial; Venous Cannulae (FEMS) (K140208)
  • Jan 30, 2026Listing added: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Aortic Perfusion Cannulae - EZ Glide (K123370)
  • Mar 31, 2026Listing added: DWF — Thruport Endoplege Coronary Sinus Catheter (K964248)
  • Mar 31, 2026Listing added: DWF — Anastaflo Intravascular Shunts (K990396)
  • Dec 18, 2025Listing added: DWF — QuickDraw™ Plus Venous Cannula (QDP25) (K200499)
  • Mar 31, 2026Listing added: DWF — Suction Wands and Sumps (K831759)
  • Jan 15, 2026Listing added: DWF — Fem-Flex II Femoral Arterial Cannula; Fem-Flex II Femoral Venous Cannula; Femoral Venous Cannula (K200358)
  • Mar 31, 2026Listing added: DQO — Left Atrial Pressure Monitoring Catheter (K110103)
  • Mar 31, 2026Listing added: DQO — FAPCath Femoral arterial pressure monitoring catheter (K852456)
  • Jan 15, 2026Listing added: DXC — Intraclude Intra-Aortic Occlusion Device (K113182)
  • Jan 15, 2026Listing added: DXC — IntraClude Intra-Aortic Occlusion Catheter (K132175)
  • Mar 31, 2026Listing added: DXC — Thruport Endoclamp Aortic Catheters (K964161)
  • Mar 31, 2026Listing added: DXC — Thruport Endoclamp Aortic Catheters (K955132)
  • Mar 31, 2026Listing added: DXC — Port Access EV cardiopulmonary bypass system (K962858)
  • Mar 31, 2026Listing added: DXC — Thruport Endoclamp Aortic Catheters (K962510)
  • Mar 31, 2026Listing added: DRE — Dilator Kit (K093554)
  • Mar 31, 2026Listing added: DTM — EMBOL-X ARTERIAL FILTER (K031946)
  • Mar 31, 2026Listing added: DTM — EMBOL-X ARTERIAL FILTER (K022071)
  • Mar 31, 2026Listing added: DTM — Embol-X Arterial Filter (K062429)
  • Mar 31, 2026Listing added: DYB — EMBOL-X Introducer Sheath; EXIS (K123714)
  • Jan 29, 2026Listing added: DYB — Introducer, Catheter - Introducer Sheath (IS19A) (K972570)
  • Mar 31, 2026Listing added: DYB — INTRODUCER SHEATH KIT,11 FR (K131627)
  • Mar 31, 2026Listing added: DYB — INTRODUCER SHEATH KIT, 9 FR (K121185)
  • Mar 31, 2026Listing added: FQH — VisuFlo Blower (K922083)
  • Mar 31, 2026Listing added: DWD — Duraflo-Treated Suction Wands (K905311)
  • Jun 1, 2026Listing added: MWS — Janke-Barron Heart Support
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

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