Surefire Infusion System 021
FDA 510(k) K143588 · Surefire Medical, Inc.
510(k) numberK143588
Submission
- Device name
- Surefire Infusion System 021
- Applicant
- Surefire Medical, Inc.
Westminster, CO, US - Received
- December 18, 2014
- Decision date
- January 12, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K180677 | Surefire Spark Infusion SystemDQO · Traditional | 04/03/2018SE |
| K171355 | Surefire Precision Infusion SystemDQO · Special | 05/17/2017SE |
| K162359 | Surefire Guiding CatheterDQY · Special | 09/21/2016SE |
| K160662 | Surefire Infusion SystemDQO · Special | 03/11/2016SE |
| K140034 | Surefire Guiding CatheterDQY · Traditional | 02/26/2014SE |
| K122506 | Surefire High Flow Angiographic Catheter, AccessDQX · Traditional | 09/17/2012SE |
| K121677 | Surefire Hi-Flow MicrocatheterDQO · Traditional | 06/14/2012SE |
| K113737 | Surefire Guide SheathDQO · Special | 02/23/2012SE |
| K110459 | Surefire Infusion Catheter SystemDQO · Traditional | 06/24/2011SE |
Questions and answers
When was Surefire Infusion System 021 cleared by the FDA?
Surefire Infusion System 021 (K143588) received a 510(k) decision of Substantially Equivalent on January 12, 2015, 25 days after the submission was received.
What is the product code of K143588?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.