510(k) K121677
K121677 is an FDA 510(k) premarket notification submitted by Surefire Medical, Inc. for the device "SUREFIRE HI-FLOW MICROCATHETER". The FDA issued a decision of Substantially Equivalent on Jun 14, 2012. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Surefire Medical, Inc. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 14, 2012
- Date Received
- Jun 7, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)