CENTERPOINT SYSTEMS LLC
Registration 3015970743FEI 3015970743West Valley City, UT
Owner/operator: CenterPoint Systems LLC
- Complaint File Establishment per 21 CFR 820.198
- 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
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 24
- Added, last 12 months
- 7
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
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 processWait 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 processRenew 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 listingReview 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 24
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| EOQ | Recon Steerable SheathBronchoscope (Flexible Or Rigid)Added Mar 30, 2026 | Class 2 | 21 CFR 874.4680 | — |
| KTI | Compass Steerable NeedleBronchoscope AccessoryAdded Nov 19, 2025 | Class 2 | 21 CFR 874.4680 | — |
| KTI | Compass Steerable Needle with Adapaters SRA-1-01 and SRA-2-01Bronchoscope AccessoryAdded Nov 19, 2025 | Class 2 | 21 CFR 874.4680 | — |
| DQY | CPS Locator 3D Plus Delivery CatheterCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | K250828 |
| DQY | SSPC NXT Delivery CatheterCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | K243180 |
| DQY | SSPC NXT Delivery CatheterCatheter, PercutaneousAdded Sep 1, 2026 | Class 2 | 21 CFR 870.1250 | K262240 |
| DQY | SSPC Delivery CatheterCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | K190475 |
| DQY | CPS Locator 3D Plus Delivery CatheterCatheter, PercutaneousAdded Jul 30, 2026 | Class 2 | 21 CFR 870.1250 | K261766 |
| DQY | CPS Locator 3D Delivery CatheterCatheter, PercutaneousAdded Jul 6, 2026 | Class 2 | 21 CFR 870.1250 | K250147 |
| DQY | CPS Locator 3D Delivery CatheterCatheter, Percutaneous | Class 2 | 21 CFR 870.1250 | K230363 |
| DRA | AuST Steerable SheathCatheter, Steerable | Class 2 | 21 CFR 870.1280 | K242106 |
| DRA | AuST Steerable SheathCatheter, Steerable | Class 2 | 21 CFR 870.1280 | K240829 |
and 12 more on your full dossier
What changed
- Mar 30, 2026Listing added: EOQ — Recon Steerable Sheath
- Nov 19, 2025Listing added: KTI — Compass Steerable Needle
- Nov 19, 2025Listing added: KTI — Compass Steerable Needle with Adapaters SRA-1-01 and SRA-2-01
- Sep 1, 2026Listing added: DQY — SSPC NXT Delivery Catheter (K262240)
- Jul 30, 2026Listing added: DQY — CPS Locator 3D Plus Delivery Catheter (K261766)
- Jul 6, 2026Listing added: DQY — CPS Locator 3D Delivery Catheter (K250147)
- May 19, 2026Listing added: DYB — AuST Steerable Sheath (K260942)