Surefire Precision Infusion System
FDA 510(k) K171355 · Surefire Medical, Inc.
510(k) numberK171355
Submission
- Device name
- Surefire Precision Infusion System
- Applicant
- Surefire Medical, Inc.
Westminster, CO, US - Received
- May 9, 2017
- Decision date
- May 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K180677 | Surefire Spark Infusion SystemDQO · Traditional | 04/03/2018SE |
| K162359 | Surefire Guiding CatheterDQY · Special | 09/21/2016SE |
| K160662 | Surefire Infusion SystemDQO · Special | 03/11/2016SE |
| K143588 | Surefire Infusion System 021DQO · Traditional | 01/12/2015SE |
| 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 Precision Infusion System cleared by the FDA?
Surefire Precision Infusion System (K171355) received a 510(k) decision of Substantially Equivalent on May 17, 2017, 8 days after the submission was received.
What is the product code of K171355?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.