Medical Device Manufacturer · US , Plymouth , MN

Aga Medical Corporation - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2012

Recent clearances: AMPLATZER TORQVUE FX, AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Aga Medical Corporation Cardiovascular ✕

2 devices

1-2 of 2

Cleared Aug 23, 2012

AMPLATZER TORQVUE FX

Cardiovascular · 83d

Cleared Mar 15, 2012

AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH...

Cardiovascular · 58d