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Sign in to claim this brandSurefire Medical, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 6272 W 91st Ave, Westminster, CO, 80031
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3010909876
- DUNS Number
- —
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surefire Spark Infusion System | SPARK-A120 | FDA UDI | Class II | Active |
| Surefire Infusion System | SHF-38120-mT | FDA UDI | Class II | Active |
| TriNav LV Infusion System | TVM-25150-50 | FDA UDI | Class II | Active |
| Surefire Guiding Catheter | SGC-5065-Sim1 | FDA UDI | Class II | Active |
| Surefire Precision Infusion System | SPS-21150-35 | FDA UDI | Class II | Active |
| TriNav Infusion System | TNV-21150-35 | FDA UDI | Class II | Active |
| Surefire Precision Infusion System | SPS-25150-40 | FDA UDI | Class II | Active |
| TriNav FLX Infusion System | FLX-21120-35 | FDA UDI | Class II | Active |
| Surefire Infusion System | SHF-38120-LT | FDA UDI | Class II | Active |
| TriGuide Guiding Catheter | TGC-48065-Sim1 | FDA UDI | Class II | Active |
| Surefire Precision Infusion System | SPS-25120-40 | FDA UDI | Class II | Active |
| TriNav Infusion System | TNV-21120-35 | FDA UDI | Class II | Active |
| Surefire Guiding Catheter | SGC-5065-Axis | FDA UDI | Class II | Active |
| TriSalus Infusion System | TIS-21120-60 | FDA UDI | Class II | Active |
| SIS Adaptor | STA-0001 | FDA UDI | Class I | Active |
| Surefire Guiding Catheter | SGC-5065-Cobra1 | FDA UDI | Class II | Active |
| Surefire Precision Infusion System | SPS-25150-60 | FDA UDI | Class II | Active |
| Surefire Precision Infusion System | SPS-25120-60 | FDA UDI | Class II | Active |
| Surefire Precision Infusion System | SPS-21120-35 | FDA UDI | Class II | Active |
| TriNav FLX Infusion System | FLX-21150-35 | FDA UDI | Class II | Active |
| TriGuide Guiding Catheter | TGC-48065-Axis | FDA UDI | Class II | Active |
| Surefire Spark Infusion System | SPARK-A150 | FDA UDI | Class II | Active |
| TriNav LV Infusion System | TVM-25120-50 | FDA UDI | Class II | Active |
| Surefire Flexion Guiding Catheter | SSG-5080-Axis | FDA UDI | Class II | Active |
| TriGuide Guiding Catheter | TGC-48065-Cobra | FDA UDI | Class II | Active |
| Surefire Flexion Guiding Catheter | SSG-5080-Sim1 | FDA UDI | Class II | Active |
| Surefire Infusion Catheter System | K110459 | FDA 510(k) | Class II | Active |
| Surefire Guiding Catheter | K140034 | FDA 510(k) | Class II | Active |
| Surefire High Flow Angiographic Catheter, Access | K122506 | FDA 510(k) | Class II | Active |
| Surefire Precision Infusion System | K171355 | FDA 510(k) | Class II | Active |
| Surefire Spark Infusion System | K180677 | FDA 510(k) | Class II | Active |
| Surefire Hi-Flow Microcatheter | K121677 | FDA 510(k) | Class II | Active |
| Surefire Infusion System | K160662 | FDA 510(k) | Class II | Active |
| Surefire Guiding Catheter | K162359 | FDA 510(k) | Class II | Active |
| Surefire Guide Sheath | K113737 | FDA 510(k) | Class II | Active |
| Surefire Infusion System 021 | K143588 | FDA 510(k) | Class II | Active |
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