The following data is part of a premarket notification filed by Surefire Medical, Inc. with the FDA for Surefire Hi-flow Microcatheter.
| Device ID | K121677 |
| 510k Number | K121677 |
| Device Name: | SUREFIRE HI-FLOW MICROCATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SUREFIRE MEDICAL, INC. 12415 SW 136 AVENUE UNIT 3 Miami, FL 33186 |
| Contact | Mario Arbesu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-06-07 |
| Decision Date | 2012-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857136004040 | K121677 | 000 |
| 00857136004019 | K121677 | 000 |