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FDA 510(k)

Highlander™ 014 PTA Balloon Dilatation Catheter

K-Number: K223177 · 2023-01-20

ApplicantC.R. Bard, Inc.
Decision Date2023-01-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Highlander™ 014 PTA Balloon Dilatation Catheter is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2023-01-20 under approval number K223177. 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 Highlander™ 014 PTA Balloon Dilatation Catheter?

Highlander™ 014 PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-01-20. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K223177.

When was Highlander™ 014 PTA Balloon Dilatation Catheter approved by the FDA?

Highlander™ 014 PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-01-20, under approval number K223177.

What company makes Highlander™ 014 PTA Balloon Dilatation Catheter?

Highlander™ 014 PTA Balloon Dilatation Catheter is manufactured by C.R. Bard, Inc..

What is the FDA product code for Highlander™ 014 PTA Balloon Dilatation Catheter?

The FDA product code for Highlander™ 014 PTA Balloon Dilatation Catheter is LIT.

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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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