# K121083: True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True Dilatation Percutaneous Translumina

- Pathway: 510(k) (Traditional)
- Applicant: Loma Vista Medical
- Decided: Oct 11, 2012 after 184 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
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K082776: NuCLEUS. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K133569: True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM (2013), 9 descendants of its own
- K142083: True Flow Valvuloplasty Perfusion Catheter (2015), 3 descendants of its own
- K141985: True BA V Balloon Valvuloplasty Catheter (2014), 3 descendants of its own
- K212588: Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter (2022), 2 descendants of its own
- K152613: True Flow Valvuloplasty Perfusion Catheter (2016), 2 descendants of its own

## Recalls of this device
- Mar 18, 2013 · Class II · Z-1566-2013: Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time

## Indications for use
The TRUE Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Source page: https://510kreport.com/device/K121083
Methodology: https://510kreport.com/methodology