510(k) K123311
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2013
- Date Received
- October 25, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type