# K083657: Conquest Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 24, 2008 after 14 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001134 (2000). 18 ancestors in all.
44 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014212: Bard Conquest Pta Balloon Dilatation Catheter, C.R. Bard, Inc. (2002) Summary page 1.
- K072283: Dorado Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2007) Summary page 1.
- K052149: Edwards Peripheral Dilation Catheter, Edwards Lifesciences, LLC (2005) Summary page 1.

## Most influential descendants
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own
- K112182: Angiosculpt Pta Scoring Balloon Catheter (2011), 29 descendants of its own
- K122685: Angiosculpt Pta Scoring Balloon Catheter (2013), 28 descendants of its own
- K133998: Angiosculpt Pta Scoring Balloon with Hydrocross Caoting (2014), 24 descendants of its own
- K142983: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating (2015), 16 descendants of its own

## Recalls of this device
- Oct 1, 2020 · Class II · Z-0080-2021: Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter 
- Mar 23, 2015 · Class II · Z-1413-2015: Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.

## Indications for use
The ConquestTM PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K083657
Methodology: https://510kreport.com/methodology