510(k) · Cleared
Recalled · Class II · 2020Conquest Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 24, 2008 as substantially equivalent to K014212 (C.R. Bard, Inc., 2002) and 2 other predicates after a 14-day review. Its family tree reaches back 5 generations to 2000. 44 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 24, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001134 (2000). 18 ancestors in all, the oldest K993720 (2000). 44 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 4 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 3 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 2 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 1 generation backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- This deviceK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008
- Descendant · cites it directly · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- Descendant · 2 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- Descendant · 3 generations on · 28 of its ownK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- Descendant · 2 generations on · 24 of its ownK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
- Descendant · 3 generations on · 16 of its ownK142983 AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc. · 2015
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · cites it directly36descendants
- K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 2 generations on29descendants
- K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013 · 3 generations on28descendants
- K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014 · 2 generations on24descendants
- K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc. · 2015 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −4 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −3 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −2 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −1 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| 0 (this device) | K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | — |
| +1 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
| +2 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| +3 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | — |
| +2 | K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross Caoting | Angioscore, Inc. | 2014 | — |
| +3 | K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Angioscore, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014212 | Bard Conquest Pta Balloon Dilatation CatheterSummary page 1…Classification: Class II Classification Panel: Cardiovascular Predicate Devices: · Conquest TM PTA Balloon Dilatation Catheter (K014212; cleared January 17, 2002) * Dorado TM PTA Balloon Dilatation Catheter (K072283; cleared September 19… | 2002 |
| * | K072283 | Dorado Pta Balloon Dilatation CatheterSummary page 1…edicate Devices: · Conquest TM PTA Balloon Dilatation Catheter (K014212; cleared January 17, 2002) * Dorado TM PTA Balloon Dilatation Catheter (K072283; cleared September 19, 2007) * Edwards Peripheral Dilatation Catheter (K052149; cleared September 2,… | 2007 |
| * | K052149 | Edwards Peripheral Dilation CatheterSummary page 1…17, 2002) * Dorado TM PTA Balloon Dilatation Catheter (K072283; cleared September 19, 2007) * Edwards Peripheral Dilatation Catheter (K052149; cleared September 2, 2005) Bard Peripheral Vascular, Inc. TRADE SECRET/CONF… | 2005 |
What descends from it? (44)
See all 443 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2020 | Class II | Z-0080-2021 | Labeling Change Control | 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 than expected could result in… |
| Mar 23, 2015 | Class II | Z-1413-2015 | Process control | Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K103459 (C.R. Bard, Inc., 2010) has gone furthest, with 36 descendants of its own.
- 3 other devices also cite its predicate K014212.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083657 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083657: Conquest Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083657
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026