AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K080757
Device Name AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, 
MN 
55442

Applicant Contact rashmi bhushan
Correspondent
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, 
MN 
55442

Correspodent Contact rashmi bhushan
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 03/18/2008
Decision Date 04/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No