FDA 510(k)

CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter

Número K: K241244 · 2024-10-16

Data da decisão2024-10-16

Código do produtoQJP

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cerenovus, Inc.. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K241244. 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 CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter?

CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Cerenovus, Inc.. The 510(k) number is K241244.

When did CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter receive FDA 510(k) clearance?

CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter received FDA 510(k) clearance on 2024-10-16, under 510(k) number K241244.

Who is the listed applicant for CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter?

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

What is the FDA product code for CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter?

The FDA product code for CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter is QJP.

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Fonte oficial

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