510(k) · Cleared
ClearedBard Utaverse Small Vessel 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 Sep 28, 2001 after a 29-day review. The FDA summary names its predicate without a number. 107 later devices descend from it.
- Decided
- Sep 28, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
107 later devices descend from it, 2 citing it directly.
- This deviceK012913 Bard Utaverse Small Vessel Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2001
- Descendant · cites it directly · 96 of its ownK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- Descendant · 2 generations on · 35 of its ownK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
Showing 5 of 107 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 107 · See all- K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · cites it directly96descendants
- K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 2 generations on44descendants
- K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 2 generations on36descendants
- K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · 2 generations on35descendants
- K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012913 | Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2001 | — |
| +1 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| +2 | K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 2 |
| +2 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
| +2 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| +3 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | — | Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter Named without a submission number | |
| * | — | Bard® Opti-Plast™ PTA Catheter Named without a submission number | |
| * | — | Boston Scientific Symmetry™ Balloon Dilatation Catheter Named without a submission number |
What descends from it? (107)
See all 1072 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072283 (Bard Peripheral Vascular, Inc., 2007) has gone furthest, with 96 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal vessels. This catheter is not for use in coronary arteries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012913: Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012913
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026