FDA 510(k)

METIC™- Airway Balloon Catheter

Número K: K231818 · 2023-11-15

RequerenteM/S Meril Life Sciences Pvt. , Ltd.

Data da decisão2023-11-15

Código do produtoKTI

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

METIC™- Airway Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is M/S Meril Life Sciences Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-15 under 510(k) number K231818. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the METIC™- Airway Balloon Catheter?

METIC™- Airway Balloon Catheter is a medical device that received FDA 510(k) clearance on 2023-11-15. The listed applicant is M/S Meril Life Sciences Pvt. , Ltd.. The 510(k) number is K231818.

When did METIC™- Airway Balloon Catheter receive FDA 510(k) clearance?

METIC™- Airway Balloon Catheter received FDA 510(k) clearance on 2023-11-15, under 510(k) number K231818.

Who is the listed applicant for METIC™- Airway Balloon Catheter?

The FDA 510(k) record lists M/S Meril Life Sciences Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METIC™- Airway Balloon Catheter?

The FDA product code for METIC™- Airway Balloon Catheter is KTI.

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