The following data is part of a premarket notification filed by Surefire Medical, Inc with the FDA for Surefire Infusion Catheter System.
| Device ID | K110459 |
| 510k Number | K110459 |
| Device Name: | SUREFIRE INFUSION CATHETER SYSTEM |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SUREFIRE MEDICAL, INC 8601 TURNPIKE DR SUITE 206 Westminister, CO 80031 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings SUREFIRE MEDICAL, INC 8601 TURNPIKE DR SUITE 206 Westminister, CO 80031 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-17 |
| Decision Date | 2011-06-24 |
| Summary: | summary |