FDA 510(k)

Route 92 Medical Full Length 054 Access System

Número K: K231583 · 2023-08-15

Data da decisão2023-08-15

Código do produtoQJP

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Route 92 Medical Full Length 054 Access System is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2023-08-15 under 510(k) number K231583. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Route 92 Medical Full Length 054 Access System?

Route 92 Medical Full Length 054 Access System is a medical device that received FDA 510(k) clearance on 2023-08-15. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K231583.

When did Route 92 Medical Full Length 054 Access System receive FDA 510(k) clearance?

Route 92 Medical Full Length 054 Access System received FDA 510(k) clearance on 2023-08-15, under 510(k) number K231583.

Who is the listed applicant for Route 92 Medical Full Length 054 Access System?

The FDA 510(k) record lists Route 92 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Route 92 Medical Full Length 054 Access System?

The FDA product code for Route 92 Medical Full Length 054 Access System is QJP.

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Outros registros que listam Route 92 Medical, Inc. como candidato(a)

K260220Route 92 Medical Full Length 046 Access System K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set K2405298F Sistema de Garrafa Modificada K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set K222743Route 92 Medical Full Length 070 Access System

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Dispositivos Relacionados (Código: QJP)

K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.K26227770 NeuGlide CatheterPiraeus Medical, Inc.K261176Zoom 4S CatheterImperative Care, Inc.K254071p17 XR MicrocatheterWallaby Medical K260199SLIM MicrocatheterBalt USA, LLC K253901Millipede88 Access CatheterPerfuze, Ltd.

Fonte oficial

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