510(k) K093252
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2009
- Date Received
- October 16, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type