FDA 510(k)

Cateter Angel

Número K: K160747 · 2016-07-28

Data da decisão2016-07-28

Código do produtoPNS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Angel Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Bio2 Medical, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K160747. The device is classified under product code PNS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Angel Catheter?

Angel Catheter is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Bio2 Medical, Inc.. The 510(k) number is K160747.

When did Angel Catheter receive FDA 510(k) clearance?

Angel Catheter received FDA 510(k) clearance on 2016-07-28, under 510(k) number K160747.

Who is the listed applicant for Angel Catheter?

The FDA 510(k) record lists Bio2 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Angel Catheter?

The FDA product code for Angel Catheter is PNS.

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