AMPLATZER TORQVUE DELIVERY SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K072313
Device Name AMPLATZER TORQVUE DELIVERY SYSTEM
Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, 
MN 
55442

Applicant Contact patricia a laforte
Correspondent
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, 
MN 
55442

Correspodent Contact patricia a laforte
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 08/17/2007
Decision Date 11/02/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls