510(k) K760387
K760387 is an FDA 510(k) premarket notification submitted by B. Braun Instruments for the device "CATHETER, CAVA (CAVAFIX)". The FDA issued a decision of Substantially Equivalent on November 2, 1976. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. B. Braun Instruments has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1976
- Date Received
- August 5, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type