AuST Steerable Sheath— 510(k) K260942
Substantially EquivalentCenterPoint Systems, LLC
FDA 510(k) clearance K260942 for AuST Steerable Sheath, Substantially Equivalent on 2026-04-07. Applicant: CenterPoint Systems, LLC. Device class: 2.
Summary
CenterPoint Systems' AuST Steerable Sheath is filed under product code DYB (Introducer, Catheter).
Class II, 21 CFR 870.1340. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).
CenterPoint Systems filed from West Valley City, Utah. The record shows 18 calendar days from receipt to decision (March 20 to April 7, 2026).
Clearance details
- Applicant
- CenterPoint Systems, LLC
- Product code
- Product code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Valley City, UT, US
Recent devices under product code DYB
view allMore clearances from CenterPoint Systems, LLC
view allAdverse 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, through . 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.