# Intervalve, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 5 (2013–2015): 5 510(k) clearances
- Product codes: OZT (5)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- NuMED, Inc.: 4 (https://510kreport.com/company/numed)

## Its most-cited devices
- K123111: V8 Transluminal Bav Catheter (2013), cited by 2
- K132728: V8 Transluminal Bav Catheter (2013), cited by 1
- K150343: V8 Transluminal BAV Catheter (2015), cited by 1
- K133607: V8 Transluminal Bav Catheter (2014), cited by 1

## Recent decisions
- K152150: V8 Balloon Aortic Valvuloplasty Catheter (Dec 18, 2015)
- K150343: V8 Transluminal BAV Catheter (Apr 3, 2015)
- K133607: V8 Transluminal Bav Catheter (Feb 11, 2014)
- K132728: V8 Transluminal Bav Catheter (Nov 22, 2013)
- K123111: V8 Transluminal Bav Catheter (Jan 31, 2013)

Source page: https://510kreport.com/company/intervalve