Medical Device Manufacturer · US , Minneapolis , MN

Intervalve, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2013

Recent clearances: V8 Balloon Aortic Valvuloplasty Catheter, V8 Transluminal BAV Catheter, V8 TRANSLUMINAL BAV CATHETER

View 5 510(k) Devices ↓
5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Intervalve, Inc. Cardiovascular ✕

5 devices
1-5 of 5
Cleared Dec 18, 2015
V8 Balloon Aortic Valvuloplasty Catheter
K152150 · OZT
Cardiovascular · 137d
Cleared Apr 03, 2015
V8 Transluminal BAV Catheter
K150343 · OZT
Cardiovascular · 51d
Cleared Feb 11, 2014
V8 TRANSLUMINAL BAV CATHETER
K133607 · OZT
Cardiovascular · 78d
Cleared Nov 22, 2013
V8 TRANSLUMINAL BAV CATHETER
K132728 · OZT
Cardiovascular · 80d
Cleared Jan 31, 2013
V8 TRANSLUMINAL BAV CATHETER
K123111 · OZT
Cardiovascular · 120d
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