# Surefire Medical, Inc.

- Location (FDA's records): Westminster, CO
- FDA decisions: 10 (2011–2018): 10 510(k) clearances
- Product codes: DQO (7), DQY (2), DQX (1)
- 510(k) review time since 2016: median 14 days, against 147 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 12 (8 its own); citations of its devices by later devices: 11 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- AngioDynamics, Inc.: 1 (https://510kreport.com/company/angiodynamics)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- Biosphere Medical, S.A.: 1 (https://510kreport.com/company/biosphere-medical)

## Firms that cite its devices most
- Trisalus Life Sciences: 3 (https://510kreport.com/company/trisalus-life-sciences)

## Its most-cited devices
- K140034: Surefire Guiding Catheter (2014), cited by 2
- K171355: Surefire Precision Infusion System (2017), cited by 2
- K143588: Surefire Infusion System 021 (2015), cited by 2
- K110459: Surefire Infusion Catheter System (2011), cited by 2
- K121677: Surefire HI-Flow Microcatheter (2012), cited by 1
- K160662: Surefire Infusion System (2016), cited by 1

## Recent decisions
- K180677: Surefire Spark Infusion System (Apr 3, 2018)
- K171355: Surefire Precision Infusion System (May 17, 2017)
- K162359: Surefire Guiding Catheter (Sep 21, 2016)
- K160662: Surefire Infusion System (Mar 11, 2016)
- K143588: Surefire Infusion System 021 (Jan 12, 2015)
- K140034: Surefire Guiding Catheter (Feb 26, 2014)
- K122506: Surefire High Flow Angiographic Catheter, Access (Sep 17, 2012)
- K121677: Surefire HI-Flow Microcatheter (Jun 14, 2012)

Source page: https://510kreport.com/company/surefire-medical