The following data is part of a premarket notification filed by Surefire Medical, Inc with the FDA for Surefire Guide Sheath.
| Device ID | K113737 |
| 510k Number | K113737 |
| Device Name: | SUREFIRE GUIDE SHEATH |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SUREFIRE MEDICAL, INC 12415 SW 136 AVENUE UNIT 3 Miami, FL 33186 |
| Contact | Mario Arbesu |
| Correspondent | Mario Arbesu SUREFIRE MEDICAL, INC 12415 SW 136 AVENUE UNIT 3 Miami, FL 33186 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-20 |
| Decision Date | 2012-02-23 |
| Summary: | summary |