The following data is part of a premarket notification filed by Surefire Medical, Inc. with the FDA for Surefire Spark Infusion System.
| Device ID | K180677 |
| 510k Number | K180677 |
| Device Name: | Surefire Spark Infusion System |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Surefire Medical, Inc. 6272 W. 91st Ave Westminster, CO 80031 |
| Contact | Lynne Aronson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-03-15 |
| Decision Date | 2018-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857136004286 | K180677 | 000 |
| 00857136004279 | K180677 | 000 |