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FDA 510(k)

Cáteter de Ventilação AeroJet

Número K: K243579 · 2025-08-13

RequerentePipeline Medical Products, LLC
Data da decisão2025-08-13
Código do produtoBTR
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

AeroJet Ventilation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pipeline Medical Products, LLC. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K243579. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AeroJet Ventilation Catheter?

AeroJet Ventilation Catheter is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Pipeline Medical Products, LLC. The 510(k) number is K243579.

When did AeroJet Ventilation Catheter receive FDA 510(k) clearance?

AeroJet Ventilation Catheter received FDA 510(k) clearance on 2025-08-13, under 510(k) number K243579.

Who is the listed applicant for AeroJet Ventilation Catheter?

The FDA 510(k) record lists Pipeline Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AeroJet Ventilation Catheter?

The FDA product code for AeroJet Ventilation Catheter is BTR.

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