FDA 510(k)

Codman EDS3 CSF External Drainage System

K-번호: K162437 · 2016-10-28

결정일2016-10-28

제품 코드JXG

자문 위원회NE

결정Substantially Equivalent

기기 요약

Codman EDS3 CSF External Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2016-10-28 under 510(k) number K162437. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Codman EDS3 CSF External Drainage System?

Codman EDS3 CSF External Drainage System is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K162437.

When did Codman EDS3 CSF External Drainage System receive FDA 510(k) clearance?

Codman EDS3 CSF External Drainage System received FDA 510(k) clearance on 2016-10-28, under 510(k) number K162437.

Who is the listed applicant for Codman EDS3 CSF External Drainage System?

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

What is the FDA product code for Codman EDS3 CSF External Drainage System?

The FDA product code for Codman EDS3 CSF External Drainage System is JXG.

Codman & Shurtleff, Inc.를 신청인으로 등재한 기타 기록

K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set K191237CERENOVUS Large Bore Catheter K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)K171862GALAXY G3 Mini Microcoil Delivery System

11개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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