510(k) · Cleared
ClearedConquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty 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 May 4, 2022 as substantially equivalent to K120660 (Bard Peripheral Vascular, Inc., 2012) and 3 other predicates after a 261-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.
- Decided
- May 4, 2022
- Review
- 261 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K933483 (1993). 36 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 7 generations backK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- 6 generations backK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- 5 generations backK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- 4 generations backK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- 3 generations backK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
- 2 generations backK131002 Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
- 1 generation backK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
- This deviceK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK251915 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| −7 | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| −6 | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| −5 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| −4 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| −3 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| −2 | K131002 | Vida PTV Dilataton Catheter | C.R. Bard, Inc. | 2013 | — |
| −1 | K141985 | True BA V Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2014 | — |
| 0 (this device) | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida… | C.R. Bard, Inc. | 2022 | — |
| +1 | K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2024 | — |
| +2 | K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K120660 | Conquest 40 Pta Dilatation CatheterSummary page 7…ew Panel: Cardiovascular Regulation Number: 21 CFR 870.1250 Predicate Device #1: Conquest™ 40 PTA Dilatation Catheter (K120660; cleared March 15, 2012)… | 2012 |
| * | K181323 | Atlas Gold PTA Dilatation CatheterSummary page 10…lass II Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1250 Predicate Device #2: Atlas™ Gold PTA Dilatation Catheter (K181323; cleared August 03, 2018) Reference Device: True™ Dilatation Balloon Valvuloplasty Catheter (K150667; cleared June… | 2018 |
| * | K131002 | Vida PTV Dilataton CatheterSummary page 12…Class II Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1250 Predicate Device #3: Vida™ PTV Dilatation Catheter (K131002; cleared July 02, 2013) Reference Device: True™ Dilatation Balloon Valvuloplasty Catheter (K150667; cleared June… | 2013 |
| * | K141985 | True BA V Balloon Valvuloplasty CatheterSummary page 14…II Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1255 Predicate Device #4: True™ BAV Balloon Valvuloplasty Catheter (K141985; cleared September 18, 2014) Reference Device: True™ Dilatation Balloon Valvuloplasty Catheter (K150667; cleared J… | 2014 |
| † | K150667 | True Dilatation Balloon Valvuloplasty Catheter | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241040 | Amethyst HP PTA OTW 0.035 Catheter | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 6 of the 36 ancestors have a recall of any class.
- Of its descendants, K241040 (Natec Medical, Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120660.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Conquest™ 40 PTA 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 stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. The Atlas™ Gold PTA Dilatation Catheter is…
Read the full statement (184 words)
The Conquest™ 40 PTA 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 stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Atlas™ Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Vida™ PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
• A patient with isolated pulmonary valve stenosis.
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
The VidaTM BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212588: Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212588
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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