FDA 510(k)

R350 가이드웨이, Spectre 가이드웨이, Raider 가이드웨이, Bandit 가이드웨이, Warrior 가이드웨이

K-번호: K212167 · 2022-02-09

결정일2022-02-09

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

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기기 요약

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K212167. 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 R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K212167.

When did R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire receive FDA 510(k) clearance?

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire received FDA 510(k) clearance on 2022-02-09, under 510(k) number K212167.

Who is the listed applicant for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

The FDA 510(k) record lists Vascular Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

The FDA product code for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is DQX.

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