510(k) K965249
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1997
- Date Received
- December 12, 1996
- 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