8F FlowGate2 Balloon Guide Catheter
FDA 510(k) K153729 · Concentric Medical
510(k) numberK153729
Submission
- Device name
- 8F FlowGate2 Balloon Guide Catheter
- Applicant
- Concentric Medical
Mountain View, CA, US - Received
- December 28, 2015
- Decision date
- January 27, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was 8F FlowGate2 Balloon Guide Catheter cleared by the FDA?
8F FlowGate2 Balloon Guide Catheter (K153729) received a 510(k) decision of Substantially Equivalent on January 27, 2016, 30 days after the submission was received.
What is the product code of K153729?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.