510(k) K090613
CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 by
St. Jude Medical, Cardiac Rhythm Management Divisi
— Product Code DQY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2009
- Date Received
- March 6, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type