FDA 510(k)

Worker Guidewire

K-번호: K160785 · 2016-12-08

결정일2016-12-08

제품 코드DQX

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

Worker Guidewire 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 2016-12-08 under 510(k) number K160785. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Worker Guidewire?

Worker Guidewire is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K160785.

When did Worker Guidewire receive FDA 510(k) clearance?

Worker Guidewire received FDA 510(k) clearance on 2016-12-08, under 510(k) number K160785.

Who is the listed applicant for Worker Guidewire?

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 Worker Guidewire?

The FDA product code for Worker Guidewire is DQX.

Argon Medical Devices, Inc.를 신청인으로 등재한 기타 기록

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