FieldFlex Steerable Sheath— 510(k) K261492

Name: FDA 510(k) clearance K261492
Creator: U.S. Food and Drug Administration
Published: 2026-06-05

Substantially Equivalent

CenterPoint Systems, LLC

FDA 510(k) clearance K261492 for FieldFlex Steerable Sheath, Substantially Equivalent on 2026-06-05. Applicant: CenterPoint Systems, LLC. Device class: 2.

Clearance details

Applicant: CenterPoint Systems, LLC
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2026-05-06
Decision date: 2026-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

view all

K253526 — NAMIC Dilator and Sheath2026-07-29
K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
K261242 — SimplGuide2026-06-25
K261950 — Health Line Tearaway Introducer2026-06-22
K260606 — Echo Large Bore Introducer Sheath2026-04-29

More clearances from CenterPoint Systems, LLC

view all

K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
K262240 — SSPC NXT Delivery Catheter2026-07-29
K260942 — AuST Steerable Sheath2026-04-07
K260163 — AuST CSP Introducer2026-02-19
K250828 — CPS Locator 3D Plus Delivery Catheter2025-06-27

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.