Aventus Introducer Sheath— 510(k) K260091
Substantially EquivalentInquis Medical
FDA 510(k) clearance K260091 for Aventus Introducer Sheath, Substantially Equivalent on 2026-04-13. Applicant: Inquis Medical. Device class: 2.
Summary
Inquis Medical's Aventus Introducer 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, and it came in as a Traditional 510(k).
Inquis Medical filed from Menlo Park, California. The decision came 91 calendar days after FDA received it (January 12 to April 13, 2026).
Clearance details
- Applicant
- Inquis Medical
- 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
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code DYB
view allMore clearances from Inquis Medical
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.