Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015970743

FEI Number

3015970743

Entity Name

CENTERPOINT SYSTEMS LLC

City/State/Country

West Valley City, UT, US

Establishment Address

3338 Parkway Blvd., West Valley City, UT 84119, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

CenterPoint Systems LLC (Owner Number: 10061099)

Owner / Operator Contact Address

3338 PARKWAY BLVD, West Valley City, UT 84119, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223097

PMA Number

N/A

All Registered Proprietary Names

Recon Steerable Sheath AuST Steerable Sheath FARADRIVE Steerable Sheath SSPC NXT Delivery Catheter CPS Locator 3D Plus Delivery Catheter AuST Steerable Sheath LUKE BX Single Use Biopsy Forceps Helix Locking Tool DF4 Helix Locking Tool AuST Steerable Sheath RenaNav Ureteroscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2026-03-30
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-05-19
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2024-01-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-12-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-07-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-12-05
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2024-12-05
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-07-19
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2024-03-13
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2024-09-16
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-09-16
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-11-27

Official Correspondent

Conner Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CenterPoint Systems LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015970743. Last updated year: 2026. Please use registration number 3015970743 when referencing this establishment in official correspondence.