FDA 510(k)

피그테일 신장결석 캐빈 세트, Sof-Flex AQ 코팅 피그테일 신장결석 캐빈

K-번호: K182695 · 2019-06-17

결정일2019-06-17

제품 코드EYB

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Unknown

기기 요약

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-06-17 under 510(k) number K182695. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

자주 묻는 질문

What is the Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter?

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is Cook Incorporated. The 510(k) number is K182695.

When did Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter receive FDA 510(k) clearance?

Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter received FDA 510(k) clearance on 2019-06-17, under 510(k) number K182695.

Who is the listed applicant for Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter?

The FDA product code for Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter is EYB.

Cook Incorporated를 신청인으로 등재한 기타 기록

K233177네스트 VT 비트라이제이션 장치 K222254건터 풀립 비너 캡 필터 추출 세트 K223098백리 에센셜 출산 후 baloon K210734내시경적 확장기 및 세트 K203670대형 체크-플로 인트로더 K191498쿡-콤 루프 신장경부술 세트, Ultrathane 신장경부술 세트 with Mac-Loc, Ultrathane 상부공부술 세트 with Mac-Loc

146개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.