510(k) K994111
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2000
- Date Received
- December 6, 1999
- Clearance Type
- Special
- 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