결정일2025-08-13
제품 코드BTR
자문 위원회AN
결정Substantially Equivalent
기기 요약
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.
자주 묻는 질문
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.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
관련 기기 (코드: BTR)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
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공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.