510(k) K131770
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2014
- Date Received
- June 17, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type