MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K022272
Device Name MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
Original Applicant
MEDTRONIC CARDIAC SURGICAL PRODUCTS
620 watson st. sw
grand rapids, 
MI 
49504 -6393

Original Contact roger brink
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 07/15/2002
Decision Date 01/08/2003
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