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FDA 510(k)

8F FlowGate2 Balloon Guide Catheter

K-Number: K153729 · 2016-01-27

ApplicantConcentric Medical
Decision Date2016-01-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8F FlowGate2 Balloon Guide Catheter is a medical device manufactured by Concentric Medical. It received FDA 510(k) clearance on 2016-01-27 under approval number K153729. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8F FlowGate2 Balloon Guide Catheter?

8F FlowGate2 Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2016-01-27. It is manufactured by Concentric Medical. The 510(k) number is K153729.

When was 8F FlowGate2 Balloon Guide Catheter approved by the FDA?

8F FlowGate2 Balloon Guide Catheter received FDA 510(k) clearance on 2016-01-27, under approval number K153729.

What company makes 8F FlowGate2 Balloon Guide Catheter?

8F FlowGate2 Balloon Guide Catheter is manufactured by Concentric Medical.

What is the FDA product code for 8F FlowGate2 Balloon Guide Catheter?

The FDA product code for 8F FlowGate2 Balloon Guide Catheter is DQY.

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Related Devices (Code: DQY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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