AMPLATZER TORQVUE EXCHANGE SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K080994
Device Name AMPLATZER TORQVUE EXCHANGE SYSTEM
Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, 
MN 
55442

Applicant Contact michelle nivala
Correspondent
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, 
MN 
55442

Correspodent Contact michelle nivala
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 04/07/2008
Decision Date 05/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No