FDA 510(k)

PG Pro Microcatheter

Número K: K192625 · 2019-11-21

RequerenteMicroVention, Inc. A TERUMO Group Company

Data da decisão2019-11-21

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

PG Pro Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc. A TERUMO Group Company. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192625. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PG Pro Microcatheter?

PG Pro Microcatheter is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is MicroVention, Inc. A TERUMO Group Company. The 510(k) number is K192625.

When did PG Pro Microcatheter receive FDA 510(k) clearance?

PG Pro Microcatheter received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192625.

Who is the listed applicant for PG Pro Microcatheter?

The FDA 510(k) record lists MicroVention, Inc. A TERUMO Group Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PG Pro Microcatheter?

The FDA product code for PG Pro Microcatheter is DQY.

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