CPS Locator 3D Plus Delivery Catheter
CenterPoint Systems, LLC
CENTERPOINT SYSTEMS LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015970743 | 3015970743 | CENTERPOINT SYSTEMS LLC | 1 | N | 2026-01-01 | 3338 Parkway Blvd. West Valley City UT US 84119 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 232688 | 1140872860 | K260942 | AuST Steerable Sheath | DYB | 2026-04-07 |
| 232688 | 2012318117 | K251051 | AuST Steerable Sheath | DYB | 2025-04-30 |
| 232688 | 1175782227 | K250828 | CPS Locator 3D Plus Delivery Catheter | DQY | 2025-06-27 |
| 232688 | 2063370919 | K243180 | SSPC NXT Delivery Catheter | DQY | 2024-12-04 |
| 232688 | 1342567977 | K242106 | AuST Steerable Sheath | DYB | 2024-10-04 |
| 232688 | 1439513169 | K240829 | AuST Steerable Sheath | DYB | 2024-05-01 |
| 232688 | 1841252082 | K233752 | Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps | FBN | 2024-05-02 |
| 232688 | 1491326214 | K230363 | CPS Locator 3D Delivery Catheter | DQY | 2023-03-09 |
| 232688 | 1169877430 | K223097 | RenaNav Ureteroscope System | FGB | 2023-07-31 |
| 232688 | 1687994971 | K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 | DQY | 2019-06-28 |
| 232688 | 1011950441 | ||||
| 232688 | 1120573081 | ||||
| 232688 | 1525986541 | ||||
| 232688 | 1661397691 | ||||
| 232688 | 1913065776 | ||||
| 232688 | 1920273493 |
Product Codes Associated With Registrations#
PMN#
AuST Steerable Sheath
CenterPoint Systems, LLC
SSPC NXT Delivery Catheter
CenterPoint Systems, LLC
AuST Steerable Sheath
CenterPoint Systems, LLC
Dragonfly? Pancreaticobiliary Scope; Dragonfly? Digital Controller; Dragonfly? Instrument Channel Caps
CenterPoint Systems, LLC
AuST Steerable Sheath
CenterPoint Systems, LLC
RenaNav Ureteroscope System
CenterPoint Systems, LLC
CPS Locator 3D Delivery Catheter
CenterPoint Systems, LLC
Guiding Catheter
CenterPoint Systems LLC
Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4
CenterPoint Systems
GUDID#
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2026-01-29
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2026-01-29
DF4 Helix Locking Tool - The DF4 Helix Locking Tool is a sterile, single-use device compatible with pacing and/or defibrillator leads with an extendable-retractable fixation helix and an DF4 connector with terminal pin. The DF4 Helix Locking Tool is press-fit to the lead terminal pin to fix in place or, upon rotation, transfer torque to the helix electrode. The lead helix may be extended or retracted based on the direction of torque applied. The tool may also guide stylet insertion into the lead.
2025-12-03
CPS Locator 3D Delivery Catheter - The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
2025-07-07
CPS Locator 3D Delivery Catheter - The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
2025-07-07
CPS Locator 3D Delivery Catheter - The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
2025-07-07
CPS Locator 3D Delivery Catheter - The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
2025-07-07
CPS Locator 3D Delivery Catheter - The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
2025-07-07
CPS Locator 3D Delivery Catheter - The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
2025-07-07
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-03-11
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - 0-132H-S3574SAN0-SNST0
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2025-02-03
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2024-09-20
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2024-09-20
AuST Steerable Sheath - The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
2024-09-20