510(k) K910846
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- August 16, 1991
- Date Received
- February 27, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Coude
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type