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FDA 510(k)

087 Balloon Guide Catheter System

K-Number: K192525 · 2019-10-31

ApplicantQ'Apel Medical, LLC
Decision Date2019-10-31
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

087 Balloon Guide Catheter System is a medical device manufactured by Q'Apel Medical, LLC. It received FDA 510(k) clearance on 2019-10-31 under approval number K192525. 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 087 Balloon Guide Catheter System?

087 Balloon Guide Catheter System is a medical device that received FDA 510(k) clearance on 2019-10-31. It is manufactured by Q'Apel Medical, LLC. The 510(k) number is K192525.

When was 087 Balloon Guide Catheter System approved by the FDA?

087 Balloon Guide Catheter System received FDA 510(k) clearance on 2019-10-31, under approval number K192525.

What company makes 087 Balloon Guide Catheter System?

087 Balloon Guide Catheter System is manufactured by Q'Apel Medical, LLC.

What is the FDA product code for 087 Balloon Guide Catheter System?

The FDA product code for 087 Balloon Guide Catheter System is DQY.

Related Clinical Trials

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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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