The following data is part of a premarket notification filed by Surefire Medical, Inc with the FDA for Surefire High Flow Angiographic Catheter, Access.
| Device ID | K122506 |
| 510k Number | K122506 |
| Device Name: | SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2012-09-17 |
| Summary: | summary |