FDA 510(k)

arterial wand 안전 도입기와chronoFlex C로 제작된arterial 캡시터를 포함한bioGUART 기술

K-번호: K181563 · 2018-09-26

결정일2018-09-26

제품 코드DQY

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

결정대체적으로 동일

기기 요약

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is the device name listed in this FDA 510(k) record. The listed applicant is Access Scientific, LLC. It received FDA 510(k) clearance on 2018-09-26 under 510(k) number K181563. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Access Scientific, LLC. The 510(k) number is K181563.

When did The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology receive FDA 510(k) clearance?

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology received FDA 510(k) clearance on 2018-09-26, under 510(k) number K181563.

Who is the listed applicant for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

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

What is the FDA product code for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology?

The FDA product code for The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology is DQY.

Access Scientific, LLC를 신청인으로 등재한 기타 기록

K183066POWERRAND 안전 도입기와 ChronoFlex C®로 제작된 BioGUARD™ 기술-3Fr, 4Fr, 5Fr 모델의 Extended Dwell Catheter K182243CVC 와ند 안전 도입기와 밸브 탈취 가능한 셔츠 K162322POWERWAND 안전 도입기와 확장된 머리채 카테터, 3Fr. 모델

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