# K072283: Dorado Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Sep 19, 2007 after 34 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001134 (2000). 8 ancestors in all.
96 later devices descend from it; 7 cite it directly.
0 of 105 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.
- K012913: Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter, C.R. Bard, Inc. (2001) Summary page 1.
- K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx, Boston Scientific Corp (2005) Summary page 2.
- K060572: Modification to Polarcath Peripheral Dilatation System, Boston Scientific Corporation (2006) Summary page 2.

## Most influential descendants
- K083657: Conquest Pta Balloon Dilatation Catheter (2008), 44 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own
- K082579: Evercross .035 Otw Pta Dilatation Catheter (2008), 35 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

## Recalls of this device
- May 4, 2010 · Not classified · Z-2136-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2122-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2124-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2131-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2135-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2129-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2123-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2128-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2132-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2133-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2125-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2134-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2126-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2127-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa
- May 4, 2010 · Not classified · Z-2130-2010: The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separa

## Indications for use
The DoradoTM PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in the coronary arteries.

Source page: https://510kreport.com/device/K072283
Methodology: https://510kreport.com/methodology