Surefire Medical, Inc.
Westminster, CO, US
Surefire Medical, Inc. appears in FDA device records in Westminster, CO. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Surefire Medical, Inc. between 2011 and 2018. The busiest year on record is 2012, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 3 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180677 | Surefire Spark Infusion System | DQO | Substantially Equivalent | |
| K171355 | Surefire Precision Infusion System | DQO | Substantially Equivalent | |
| K162359 | Surefire Guiding Catheter | DQY | Substantially Equivalent | |
| K160662 | Surefire Infusion System | DQO | Substantially Equivalent | |
| K143588 | Surefire Infusion System 021 | DQO | Substantially Equivalent | |
| K140034 | SUREFIRE GUIDING CATHETER | DQY | Substantially Equivalent | |
| K122506 | SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS | DQX | Substantially Equivalent | |
| K121677 | SUREFIRE HI-FLOW MICROCATHETER | DQO | Substantially Equivalent | |
| K113737 | SUREFIRE GUIDE SHEATH | DQO | Substantially Equivalent | |
| K110459 | SUREFIRE INFUSION CATHETER SYSTEM | DQO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010909876 | 3010909876 | Surefire Medical, Inc. | 6272 W 91st Ave, Westminster, CO 80031 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain