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FDA 510(k)

Chameleon PTA Balloon Catheter

K-Number: K163231 · 2017-01-17

ApplicantAv Medical Technologies, Ltd.
Decision Date2017-01-17
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Chameleon PTA Balloon Catheter is a medical device manufactured by Av Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2017-01-17 under approval number K163231. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chameleon PTA Balloon Catheter?

Chameleon PTA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-01-17. It is manufactured by Av Medical Technologies, Ltd.. The 510(k) number is K163231.

When was Chameleon PTA Balloon Catheter approved by the FDA?

Chameleon PTA Balloon Catheter received FDA 510(k) clearance on 2017-01-17, under approval number K163231.

What company makes Chameleon PTA Balloon Catheter?

Chameleon PTA Balloon Catheter is manufactured by Av Medical Technologies, Ltd..

What is the FDA product code for Chameleon PTA Balloon Catheter?

The FDA product code for Chameleon PTA Balloon Catheter is LIT.

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Other Devices by Av Medical Technologies, Ltd.

K170635Chameleon PTA Balloon Catheter

Related Devices (Code: LIT)

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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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