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FDA 510(k)

Cáteter de Dilatação Balão Hidrofílico OTW 018

Número K: K242419 · 2024-11-15

RequerenteCreagh Medical Ltd. Dba Surmodics, Inc.
Data da decisão2024-11-15
Código do produtoLIT
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Creagh Medical Ltd. Dba Surmodics, Inc.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K242419. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Creagh Medical Ltd. Dba Surmodics, Inc.. The 510(k) number is K242419.

When did 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2024-11-15, under 510(k) number K242419.

Who is the listed applicant for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

The FDA 510(k) record lists Creagh Medical Ltd. Dba Surmodics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

The FDA product code for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is LIT.

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Fonte oficial

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