510(k) K082930
K082930 is an FDA 510(k) premarket notification submitted by Cardiva Medical, Inc. for the device "CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE". The FDA issued a decision of Substantially Equivalent on Feb 13, 2009. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Cardiva Medical, Inc. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 2009
- Date Received
- Oct 1, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type
- 510(k)