Surefire High Flow Angiographic Catheter, Access
FDA 510(k) K122506 · Surefire Medical, Inc.
510(k) numberK122506
Submission
- Device name
- Surefire High Flow Angiographic Catheter, Access
- Applicant
- Surefire Medical, Inc.
Miami, FL, US - Received
- August 17, 2012
- Decision date
- September 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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More from Solo Pace, Inc.
| 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 |
| K143588 | Surefire Infusion System 021DQO · Traditional | 01/12/2015SE |
| K140034 | Surefire Guiding CatheterDQY · Traditional | 02/26/2014SE |
| 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 High Flow Angiographic Catheter, Access cleared by the FDA?
Surefire High Flow Angiographic Catheter, Access (K122506) received a 510(k) decision of Substantially Equivalent on September 17, 2012, 31 days after the submission was received.
What is the product code of K122506?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.