510(k) K240578
K240578 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System". The FDA issued a decision of Substantially Equivalent on July 31, 2024. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2024
- Date Received
- March 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Intravascular, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.3375
- Review Panel
- CV
- Submission Type