510(k) K240426
K240426 is an FDA 510(k) premarket notification submitted by Inquis Medical for the device "Aventus Clot Management System". The FDA issued a decision of Substantially Equivalent on May 14, 2024. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Inquis Medical has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2024
- Date Received
- February 13, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Autotransfusion
- Device Class
- Class II
- Regulation Number
- 868.5830
- Review Panel
- CV
- Submission Type