Device Desk

Private service · Not FDA

FDA device establishment · Eden Prairie, MN

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

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-2134243As of September 30, 2026

ACIST MEDICAL SYSTEMS, INC.

Registration 2134243FEI 3001726808EDEN PRAIRIE, MN

Owner/operator: ACIST MEDICAL SYSTEMS, INC.

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

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
35
Added, last 12 months
3

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 35

CodeDeviceClassRegulationPremarket
DRQACIST RXi Mini System and AccessoriesAmplifier And Signal Conditioner, Transducer SignalClass 221 CFR 870.2060K172216
DRQACIST Rapid Exchange (RXi) System with dPRAmplifier And Signal Conditioner, Transducer SignalClass 221 CFR 870.2060—
OBIACIST Rapid Exchange System (RXi)_dPR and Navvus II MicroCatheterCatheter, Pressure Monitoring, CardiacClass 221 CFR 870.1200K233904
OBINavvus CatheterCatheter, Pressure Monitoring, CardiacClass 221 CFR 870.1200K132474
OBIACIST Rapid Exchange System (RXi) and Navvus II MicroCatheterCatheter, Pressure Monitoring, CardiacClass 221 CFR 870.1200K190473
OBJACIST HDi SystemCatheter, Ultrasound, IntravascularClass 221 CFR 870.1200K193183
OBJACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemCatheter, Ultrasound, IntravascularClass 221 CFR 870.1200K191175
OBJACIST HDi® SystemCatheter, Ultrasound, IntravascularClass 221 CFR 870.1200K173063
DXTACIST CVi® A2000 Syringe KitInjector And Syringe, AngiographicClass 221 CFR 870.1650K171646
DXTAngioTouch Handcontroller Kits (Models ATP54, ATP65, ATR54, ATL65)Injector And Syringe, AngiographicClass 221 CFR 870.1650K040298
DXTACIST Pro CartInjector And Syringe, AngiographicAdded May 14, 2026Class 221 CFR 870.1650K252653
DXTA2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold KitInjector And Syringe, AngiographicClass 221 CFR 870.1650K984231

and 23 more on your full dossier

What changed

  • May 14, 2026Listing added: DXT — ACIST Pro Cart (K252653)
  • May 14, 2026Listing added: DXT — VeraPro AMT (K252638)
  • Aug 5, 2026Listing added: IZQ — VueJect® Ultrasound Enhancing Agent Delivery System (K262115)
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.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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