FDA 510(k)

GlidePath 장기 혈액透析 캐빈터, HemoStar 장기 혈액透析 캐빈터, HemoStar XK 장기 혈액透析 캐빈터

K-번호: K190527 · 2020-03-05

결정일2020-03-05

제품 코드MSD

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Unknown

기기 요약

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters is the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K190527. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

자주 묻는 질문

What is the GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is C. R. Bard. The 510(k) number is K190527.

When did GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters receive FDA 510(k) clearance?

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters received FDA 510(k) clearance on 2020-03-05, under 510(k) number K190527.

Who is the listed applicant for GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

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

What is the FDA product code for GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

The FDA product code for GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters is MSD.

C. R. Bard를 신청인으로 등재한 기타 기록

K182281사이트라이트 8 초음파 시스템 및 쿼이 너드 트래킹 시스템과 핀포인트 GT 너드 테크 K172571ULTRASCORE 집중력 PTA baloon K170294VENTRALIGHT ST 메시와 ECHO 2 정위치 시스템 11cm(4.5”) 원형, VENTRALIGHT ST 메시와 ECHO 2 정위치 시스템 10cm x 15cm(4”x 6”) 타원형, VENTRALIGHT ST 메시와 ECHO 2 정위치 시스템 15cm(6”) 원형, VENTRALIGHT ST 메시와 ECHO 2 정위치 시스템 15cm x 20cm(6”x8”) 타원형, VENTRALIGHT ST 메시와 ECHO 2 정위치 시스템 15cm x 25cm(6”x10”) 타원형 K162193XenMatrix AB 수술 그래프

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