# K133607: V8 Transluminal Bav Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Intervalve, Inc.
- Decided: Feb 11, 2014 after 78 days
- Product code: OZT (Balloon Aortic Valvuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.1255
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN080015 (2012). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123111: V8 Transluminal Bav Catheter, Intervalve, Inc. (2013) Summary page 2.
- K132728: V8 Transluminal Bav Catheter, Intervalve, Inc. (2013) Summary page 2.
- DEN080015: Nucleus-X PTV Catheter, NuMED, Inc. (2012). Our reading of the summary gave K082776, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080015, Nucleus-X PTV Catheter (NuMED, Inc.), granted Jun 11, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K150343: V8 Transluminal BAV Catheter (2015), 1 descendant of its own
- K152150: V8 Balloon Aortic Valvuloplasty Catheter (2015), 0 descendants of its own

## Recalls of this device
- Mar 14, 2014 · Class II · Z-1621-2014: Leak issues were discovered through accelerated age testing.

## Indications for use
The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.

Source page: https://510kreport.com/device/K133607
Methodology: https://510kreport.com/methodology