# K152613: True Flow Valvuloplasty Perfusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 19, 2016 after 127 days
- Product code: OZT (Balloon Aortic Valvuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.1255
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K121083 (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)
- K142083: True Flow Valvuloplasty Perfusion Catheter, C.R. Bard, Inc. (2015) Summary page 4.

## Most influential descendants
- K172932: True Flow Valvuloplasty Perfusion Catheter (2017), 1 descendant of its own
- K241562: OutFlo Aortic Valve Dilatation Balloon Catheter (2025), 0 descendants of its own

## Indications for use
The True™ Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

Source page: https://510kreport.com/device/K152613
Methodology: https://510kreport.com/methodology