FDA 510(k)

Highlander™ 014 PTA Balloon Dilatation Catheter

Número K: K223177 · 2023-01-20

Data da decisão2023-01-20

Código do produtoLIT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Highlander™ 014 PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K223177. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K223177.

When did Highlander™ 014 PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Highlander™ 014 PTA Balloon Dilatation Catheter?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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