FDA 510(k)

Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter

Número K: K181023 · 2018-05-17

RequerenteMeril Life Sciences Private Limited

Data da decisão2018-05-17

Código do produtoLOX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Meril Life Sciences Private Limited. It received FDA 510(k) clearance on 2018-05-17 under 510(k) number K181023. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter?

Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Meril Life Sciences Private Limited. The 510(k) number is K181023.

When did Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2018-05-17, under 510(k) number K181023.

Who is the listed applicant for Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter?

The FDA 510(k) record lists Meril Life Sciences Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter?

The FDA product code for Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter is LOX.

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Outros registros que listam Meril Life Sciences Private Limited como candidato(a)

K190619Aspiron(TM) Aspiration Catheter K160961Mozec NC-Rx PTCA Baloon Dilatation Catheter

Dispositivos Relacionados (Código: LOX)

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic Ireland K261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic Ireland K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo Corporation K251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

Fonte oficial

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