Intervalve, Inc.

Medical device manufacturer in Plymouth, MN.

5510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K152150V8 Balloon Aortic Valvuloplasty CatheterOZT · Traditional 12/18/2015SE
K150343V8 Transluminal BAV CatheterOZT · Special 04/03/2015SE
K133607V8 Transluminal Bav CatheterOZT · Traditional 02/11/2014SE
K132728V8 Transluminal Bav CatheterOZT · Special 11/22/2013SE
K123111V8 Transluminal Bav CatheterOZT · Traditional 01/31/2013SE

Recalls

RecallProductInitiated
Z-1621-2014 Class IIInterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110…Leak issues were discovered through accelerated age testing. 03/14/2014Terminated