510(k) K951413
K951413 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FOGARTY-HYDRAGRIP SURGICAL CLAMPS". The FDA issued a decision of Substantially Equivalent on Aug 18, 1995. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 1995
- Date Received
- Mar 28, 1995
- 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)