# CenterPoint Systems, LLC

- Location (FDA's records): West Valley City, UT
- FDA decisions: 17 (2019–2026): 17 510(k) clearances
- Names in FDA's records: CenterPoint Systems, LLC (15); Centerpoint Systems (2)
- Product codes: DQY (9), DYB (6), FBN (1), FGB (1)
- 510(k) review time since 2016: median 64 days, against 72 for FDA's reviews in the same codes and years (9 of 16 faster)
- Predicates its devices cite: 17 (11 its own); citations of its devices by later devices: 11 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Oscor, Inc.: 1 (https://510kreport.com/company/oscor)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- STERIS Corporation: 1 (https://510kreport.com/company/steris)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)

## Its most-cited devices
- K230363: CPS Locator 3D Delivery Catheter (2023), cited by 2
- K190475: Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 (2019), cited by 2
- K251051: AuST Steerable Sheath (2025), cited by 2
- K240829: AuST Steerable Sheath (2024), cited by 1
- K260942: AuST Steerable Sheath (2026), cited by 1
- K242106: AuST Steerable Sheath (2024), cited by 1

## Recent decisions
- K261766: CPS Locator 3D Plus Delivery Catheter (Jul 29, 2026)
- K262240: SSPC NXT Delivery Catheter (Jul 29, 2026)
- K261492: FieldFlex Steerable Sheath (Jun 5, 2026)
- K260942: AuST Steerable Sheath (Apr 7, 2026)
- K260163: AuST CSP Introducer (Feb 19, 2026)
- K250147: CPS Locator 3D Delivery Catheter (Aug 22, 2025)
- K250828: CPS Locator 3D Plus Delivery Catheter (Jun 27, 2025)
- K250492: FlexiGo 3D Delivery Catheter (Jun 18, 2025)

Source page: https://510kreport.com/company/centerpoint-systems