The following data is part of a premarket notification filed by Surefire Medical, Inc. with the FDA for Surefire Guiding Catheter.
| Device ID | K140034 |
| 510k Number | K140034 |
| Device Name: | SUREFIRE GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | SUREFIRE MEDICAL, INC. 8601 TURNPIKE DR. STE 206 Westminster, CO 80031 |
| Contact | Lynne Aronson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-01-07 |
| Decision Date | 2014-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857136004071 | K140034 | 000 |
| 00857136004064 | K140034 | 000 |
| 00857136004057 | K140034 | 000 |