ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218


Device Classification Name

catheter, percutaneous

510(k) Number K021589
Device Name ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
Original Applicant
MEDTRONIC VASCULAR
7000 central ave. n.e.
minneapolis, 
MN 
55432

Original Contact karen reidt
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 05/15/2002
Decision Date 05/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls