FDA 510(k)

D·Kaptain PTA High Pressure Balloon Dilatation Catheter

K-번호: K214009 · 2023-04-05

결정일2023-04-05

제품 코드LIT

자문 위원회CV

결정Substantially Equivalent

기기 요약

D·Kaptain PTA High Pressure Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K214009. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the D·Kaptain PTA High Pressure Balloon Dilatation Catheter?

D·Kaptain PTA High Pressure Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Dk Medical Technology Co., Ltd.. The 510(k) number is K214009.

When did D·Kaptain PTA High Pressure Balloon Dilatation Catheter receive FDA 510(k) clearance?

D·Kaptain PTA High Pressure Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-04-05, under 510(k) number K214009.

Who is the listed applicant for D·Kaptain PTA High Pressure Balloon Dilatation Catheter?

The FDA 510(k) record lists Dk Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D·Kaptain PTA High Pressure Balloon Dilatation Catheter?

The FDA product code for D·Kaptain PTA High Pressure Balloon Dilatation Catheter is LIT.

Dk Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter K232207D·Kutting™ PTA Scoring Balloon Dilatation Catheter

공식 출처

FDA 데이터베이스에서 보기 →

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