510(k) K122506
K122506 is an FDA 510(k) premarket notification submitted by Surefire Medical, Inc. for the device "SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS". The FDA issued a decision of Substantially Equivalent on Sep 17, 2012. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Surefire Medical, Inc. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 17, 2012
- Date Received
- Aug 17, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type
- 510(k)