FDA 510(k)

PathBuilder Transseptal Guiding Introducer

K-번호: K212626 · 2022-03-23

신청자Shanghai Microport EP Medtech Co., Ltd.

결정일2022-03-23

제품 코드DYB

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정Substantially Equivalent

기기 요약

PathBuilder Transseptal Guiding Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K212626. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PathBuilder Transseptal Guiding Introducer?

PathBuilder Transseptal Guiding Introducer is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K212626.

When did PathBuilder Transseptal Guiding Introducer receive FDA 510(k) clearance?

PathBuilder Transseptal Guiding Introducer received FDA 510(k) clearance on 2022-03-23, under 510(k) number K212626.

Who is the listed applicant for PathBuilder Transseptal Guiding Introducer?

The FDA 510(k) record lists Shanghai Microport EP Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathBuilder Transseptal Guiding Introducer?

The FDA product code for PathBuilder Transseptal Guiding Introducer is DYB.

Shanghai Microport EP Medtech Co., Ltd.를 신청인으로 등재한 기타 기록

K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter K212625PathBuilder Transseptal Needle K211530PathBuilder Steerable Introducer

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.