Surefire Guiding Catheter
FDA 510(k) K162359 · Surefire Medical, Inc.
510(k) numberK162359
Submission
- Device name
- Surefire Guiding Catheter
- Applicant
- Surefire Medical, Inc.
Westminster, CO, US - Received
- August 23, 2016
- Decision date
- September 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| 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 |
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Questions and answers
When was Surefire Guiding Catheter cleared by the FDA?
Surefire Guiding Catheter (K162359) received a 510(k) decision of Substantially Equivalent on September 21, 2016, 29 days after the submission was received.
What is the product code of K162359?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.