The following data is part of a premarket notification filed by Surefire Medical, Inc. with the FDA for Surefire Guiding Catheter.
| Device ID | K162359 |
| 510k Number | K162359 |
| Device Name: | Surefire Guiding Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Surefire Medical, Inc. 6272 W. 91st Avenue 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 | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2016-09-21 |
| Summary: | summary |