FDA 510(k)

급성 양쪽 루미널 혈장透析 캐빗

K-번호: K200426 · 2020-12-24

신청자Health Line International Corporation

결정일2020-12-24

제품 코드MPB

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Unknown

기기 요약

Acute Dual Lumen Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2020-12-24 under 510(k) number K200426. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

자주 묻는 질문

What is the Acute Dual Lumen Hemodialysis Catheter?

Acute Dual Lumen Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2020-12-24. The listed applicant is Health Line International Corporation. The 510(k) number is K200426.

When did Acute Dual Lumen Hemodialysis Catheter receive FDA 510(k) clearance?

Acute Dual Lumen Hemodialysis Catheter received FDA 510(k) clearance on 2020-12-24, under 510(k) number K200426.

Who is the listed applicant for Acute Dual Lumen Hemodialysis Catheter?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acute Dual Lumen Hemodialysis Catheter?

The FDA product code for Acute Dual Lumen Hemodialysis Catheter is MPB.

Health Line International Corporation를 신청인으로 등재한 기타 기록

K261950헬스라인 티어어웨이 인트루저 K222170Power Acute Triple Lumen Hemodialysis Catheter K200263헬스라인 CT 미들라인 캐빗터 K192533건강라인 CT CVC K160448ARTLINE

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