FDA Registration
Active
🇺🇸 United States
CENTERPOINT SYSTEMS LLC
Reg #: 3015970743
·
FEI: 3015970743
·
Expires 2026
Products
12
Proprietary Names
16
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- CENTERPOINT SYSTEMS LLC
- Registration Number
- 3015970743
- FEI Number
- 3015970743
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3338 Parkway Blvd.
- City
- West Valley City
- State
- UT
- ZIP
- 84119
- Country
- US
Regulatory Submissions
- 510(k) Number
- K260942
Owner / Operator
- Firm Name
- CenterPoint Systems LLC
- Operator Number
- 10061099
- Address
- 3338 PARKWAY BLVD
- City
- West Valley City
- State
- UT
- Postal Code
- 84119
- Country
- US
- Correspondent
- Conner Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2026-03-30 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2026-05-19 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2024-01-22 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2024-12-05 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2024-07-19 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2024-03-13 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2023-11-27 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2025-11-19 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
Proprietary Names
Recon Steerable Sheath
AuST Steerable Sheath
FARADRIVE Steerable Sheath
SSPC NXT Delivery Catheter
CPS Locator 3D Plus Delivery Catheter
LUKE BX Single Use Biopsy Forceps
Helix Locking Tool
DF4 Helix Locking Tool
RenaNav Ureteroscope System
Compass Steerable Needle with Adapaters SRA-1-01 and SRA-2-01
Dragonfly Instrument Channel Caps
Dragonfly Pancreaticobiliary Scope
Dragonfly Digital Controller
CPS Locator 3D Delivery Catheter
SSPC Delivery Catheter
Compass Steerable Needle
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198