ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY


Device Classification Name

catheter, percutaneous

510(k) Number K024035
Device Name ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
Original Applicant
MEDTRONIC VASCULAR
7000 central avenue ne
ms cw304
minneapolis, 
MN 
55432 -3576

Original Contact lynn jensen
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 12/06/2002
Decision Date 12/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No