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FDA 510(k)

091 Balloon Guide Catheter

K-Number: K231629 · 2023-10-31

ApplicantEosolutions, Corp.
Decision Date2023-10-31
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

091 Balloon Guide Catheter is a medical device manufactured by Eosolutions, Corp.. It received FDA 510(k) clearance on 2023-10-31 under approval number K231629. 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 091 Balloon Guide Catheter?

091 Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Eosolutions, Corp.. The 510(k) number is K231629.

When was 091 Balloon Guide Catheter approved by the FDA?

091 Balloon Guide Catheter received FDA 510(k) clearance on 2023-10-31, under approval number K231629.

What company makes 091 Balloon Guide Catheter?

091 Balloon Guide Catheter is manufactured by Eosolutions, Corp..

What is the FDA product code for 091 Balloon Guide Catheter?

The FDA product code for 091 Balloon Guide Catheter is 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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