FDA 510(k)

RA-308 Excimer Laser System, Excimer Laser Catheter

Número K: K170349 · 2017-05-24

Data da decisão2017-05-24

Código do produtoPDU

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

RA-308 Excimer Laser System, Excimer Laser Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Ra Medical Systems,Inc. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K170349. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RA-308 Excimer Laser System, Excimer Laser Catheter?

RA-308 Excimer Laser System, Excimer Laser Catheter is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Ra Medical Systems,Inc. The 510(k) number is K170349.

When did RA-308 Excimer Laser System, Excimer Laser Catheter receive FDA 510(k) clearance?

RA-308 Excimer Laser System, Excimer Laser Catheter received FDA 510(k) clearance on 2017-05-24, under 510(k) number K170349.

Who is the listed applicant for RA-308 Excimer Laser System, Excimer Laser Catheter?

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

What is the FDA product code for RA-308 Excimer Laser System, Excimer Laser Catheter?

The FDA product code for RA-308 Excimer Laser System, Excimer Laser Catheter is PDU.

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Outros registros que listam Ra Medical Systems,Inc como candidato(a)

K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

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