ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY


Device Classification Name

catheter, percutaneous

510(k) Number K080428
Device Name ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
Applicant
MEDTRONIC INC.
8200 coral sea street ne
ms mv s11
mounds view, 
MN 
55112

Applicant Contact marlene peterson
Correspondent
MEDTRONIC INC.
8200 coral sea street ne
ms mv s11
mounds view, 
MN 
55112

Correspodent Contact marlene peterson
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 02/19/2008
Decision Date 12/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No