THREE STAGE VENOUS RETURN CANNULA, MODEL 816460


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K080034
Device Name THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor, 
MI 
48103

Applicant Contact andrea wallen
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor, 
MI 
48103

Correspodent Contact andrea wallen
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 01/07/2008
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls