ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K121219
Device Name ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
Applicant
MEDTRONIC INC.
8200 coral sea street
ms mvsii
mounds view, 
MN 
55112

Applicant Contact wendy saunders
Correspondent
MEDTRONIC INC.
8200 coral sea street
ms mvsii
mounds view, 
MN 
55112

Correspodent Contact wendy saunders
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 04/23/2012
Decision Date 09/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No