CIRCUIT TUBINGS WITH X-COATING


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K023056
Device Name CIRCUIT TUBINGS WITH X-COATING
Original Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton, 
MD 
21921

Original Contact kazuhito inoue
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 09/13/2002
Decision Date 11/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No