FDA 510(k)

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

Número K: K232130 · 2023-12-15

RequerenteSurgical Instrument Services and Savings, Inc.

Data da decisão2023-12-15

Código do produtoOWQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Services and Savings, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232130. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter?

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Surgical Instrument Services and Savings, Inc.. The 510(k) number is K232130.

When did Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter receive FDA 510(k) clearance?

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232130.

Who is the listed applicant for Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter?

The FDA 510(k) record lists Surgical Instrument Services and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter?

The FDA product code for Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is OWQ.

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Outros registros que listam Surgical Instrument Services and Savings, Inc. como candidato(a)

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Dispositivos Relacionados (Código: OWQ)

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Fonte oficial

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