FDA 510(k)

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit

K-번호: K191758 · 2019-12-17

결정일2019-12-17

제품 코드MMX

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

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2019-12-17 under 510(k) number K191758. The device is classified under product code MMX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit?

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K191758.

When did Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit receive FDA 510(k) clearance?

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit received FDA 510(k) clearance on 2019-12-17, under 510(k) number K191758.

Who is the listed applicant for Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit?

The FDA product code for Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit is MMX.

Argon Medical Devices, Inc.를 신청인으로 등재한 기타 기록

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