FDA 510(k)

SMARxT Tubing and Connectors

K-번호: K233702 · 2024-08-08

결정일2024-08-08

제품 코드DWE

자문 위원회CV

결정Substantially Equivalent

기기 요약

SMARxT Tubing and Connectors is the device name listed in this FDA 510(k) record. The listed applicant is LivaNova USA, Inc.. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K233702. The device is classified under product code DWE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SMARxT Tubing and Connectors?

SMARxT Tubing and Connectors is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is LivaNova USA, Inc.. The 510(k) number is K233702.

When did SMARxT Tubing and Connectors receive FDA 510(k) clearance?

SMARxT Tubing and Connectors received FDA 510(k) clearance on 2024-08-08, under 510(k) number K233702.

Who is the listed applicant for SMARxT Tubing and Connectors?

The FDA 510(k) record lists LivaNova USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARxT Tubing and Connectors?

The FDA product code for SMARxT Tubing and Connectors is DWE.

LivaNova USA, Inc.를 신청인으로 등재한 기타 기록

K250937Venous Return Cannulae K250283RAP Femoral Venous Cannulae

공식 출처

FDA 데이터베이스에서 보기 →

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

기기 요약

자주 묻는 질문

관련 임상시험

LivaNova USA, Inc.를 신청인으로 등재한 기타 기록

공식 출처