FDA 510(k)

Pacel Flow Directed Pacing Catheter

Número K: K161873 · 2016-11-22

Data da decisão2016-11-22

Código do produtoLDF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pacel Flow Directed Pacing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161873. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pacel Flow Directed Pacing Catheter?

Pacel Flow Directed Pacing Catheter is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is St Jude Medical. The 510(k) number is K161873.

When did Pacel Flow Directed Pacing Catheter receive FDA 510(k) clearance?

Pacel Flow Directed Pacing Catheter received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161873.

Who is the listed applicant for Pacel Flow Directed Pacing Catheter?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pacel Flow Directed Pacing Catheter?

The FDA product code for Pacel Flow Directed Pacing Catheter is LDF.

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