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FDA 510(k)

Apollo Balloon Dilatation Catheter

K-Number: K153742 · 2016-08-08

ApplicantBrosmed Medical Co., Ltd.
Decision Date2016-08-08
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Apollo Balloon Dilatation Catheter is a medical device manufactured by Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-08-08 under approval number K153742. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apollo Balloon Dilatation Catheter?

Apollo Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-08-08. It is manufactured by Brosmed Medical Co., Ltd.. The 510(k) number is K153742.

When was Apollo Balloon Dilatation Catheter approved by the FDA?

Apollo Balloon Dilatation Catheter received FDA 510(k) clearance on 2016-08-08, under approval number K153742.

What company makes Apollo Balloon Dilatation Catheter?

Apollo Balloon Dilatation Catheter is manufactured by Brosmed Medical Co., Ltd..

What is the FDA product code for Apollo Balloon Dilatation Catheter?

The FDA product code for Apollo Balloon Dilatation Catheter is LOX.

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Other Devices by Brosmed Medical Co., Ltd.

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Related Devices (Code: LOX)

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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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