FDA 510(k)

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

Número K: K220544 · 2022-06-29

Data da decisão2022-06-29

Código do produtoPDU

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) 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 2022-06-29 under 510(k) number K220544. 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 DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Ra Medical Systems,Inc. The 510(k) number is K220544.

When did DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) receive FDA 510(k) clearance?

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) received FDA 510(k) clearance on 2022-06-29, under 510(k) number K220544.

Who is the listed applicant for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

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 DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

The FDA product code for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) is PDU.

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

K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)K170349RA-308 Excimer Laser System, Excimer Laser Catheter

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