510(k) K912540
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- August 23, 1991
- Date Received
- June 10, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5965
- Review Panel
- HO
- Submission Type