FDA 510(k)

TSI Transseptal Introducer

K-번호: K181031 · 2018-10-26

신청자Pressure Products Medical Device Manufacturing, LLC

결정일2018-10-26

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

TSI Transseptal Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2018-10-26 under 510(k) number K181031. 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 TSI Transseptal Introducer?

TSI Transseptal Introducer is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K181031.

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

TSI Transseptal Introducer received FDA 510(k) clearance on 2018-10-26, under 510(k) number K181031.

Who is the listed applicant for TSI Transseptal Introducer?

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

What is the FDA product code for TSI Transseptal Introducer?

The FDA product code for TSI Transseptal Introducer is DYB.

Pressure Products Medical Device Manufacturing, LLC를 신청인으로 등재한 기타 기록

K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)K221707SafeSept® Transseptal Guidewire (SS-140)K210328SafeSept Blunt Needle K172950TSN Transseptal Needle K172934Needle Free Transseptal Cannula

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