510(k) K162359
K162359 is an FDA 510(k) premarket notification submitted by Surefire Medical, Inc. for the device "Surefire Guiding Catheter". The FDA issued a decision of Substantially Equivalent on Sep 21, 2016. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Surefire Medical, Inc. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2016
- Date Received
- Aug 23, 2016
- Clearance Type
- Special
- 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
- 510(k)