510(k) · Cleared
ClearedMustang Balloon Dilatation Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Mar 22, 2011 as substantially equivalent to K993305 (Boston Scientific Corp, 2000) and 1 other predicate after an 89-day review. Its family tree reaches back 5 generations to 2000. 15 later devices descend from it.
- Decided
- Mar 22, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001134 (2000). 10 ancestors in all, the oldest K993305 (2000). 15 later devices descend from it, 10 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 deviceK103751 Mustang Balloon Dilatation CathetersBoston Scientific · 2011
- Descendant · cites it directly · 2 of its ownK113681 Gladiator Pta Balloon Dilation CatheterBoston Scientific · 2012
- Descendant · cites it directly · 1 of its ownK201170 Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation · 2020
- Descendant · cites it directly · 1 of its ownK160256 Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK132810 Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014
- Descendant · cites it directly · 1 of its ownK112697 Charger Pta Ballon Dilatation CatheterBoston Scientific · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific · 2012 · cites it directly2descendants
- K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation · 2020 · cites it directly1descendant
- K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016 · cites it directly1descendant
- K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014 · 2 generations on1descendant
- K112697Charger Pta Ballon Dilatation CatheterBoston Scientific · 2011 · cites it directly1descendant
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) | K103751 | Mustang Balloon Dilatation Catheters | Boston Scientific | 2011 | — |
| +1 | K113681 | Gladiator Pta Balloon Dilation Catheter | Boston Scientific | 2012 | — |
| +1 | K201170 | Athletis PTA Balloon Dilatation Catheter | Boston Scientific Corporation | 2020 | — |
| +1 | K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016 | — |
| +2 | K132810 | Gladiator Elite Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2014 | — |
| +1 | K112697 | Charger Pta Ballon Dilatation Catheter | Boston Scientific | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K993305 | Transluminal Balloon Dilatation CatheterSummary page 1…on Catheter Product Code LIT, DQY Classification Class 11,21 CFR Part 870.1250 Predicate SC 35 Balloon Dilatation Catheter K993305 10 April 2000 Devices Bard Dorad oTM PTA Balloon K072283 19 September 2… | 2000 |
| * | K072283 | Dorado Pta Balloon Dilatation CatheterSummary page 1…cate SC 35 Balloon Dilatation Catheter K993305 10 April 2000 Devices Bard Dorad oTM PTA Balloon K072283 19 September 2007 Dilatation Catheter Device The Boston Scientific Mustang"' Bal… | 2007 |
What descends from it? (15)
See all 1510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113681 | Gladiator Pta Balloon Dilation Catheter | 2012 | 2 |
| K201170 | Athletis PTA Balloon Dilatation Catheter | 2020 | 1 |
| K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | 2016 | 1 |
| K112697 | Charger Pta Ballon Dilatation Catheter | 2011 | 1 |
| K231402 | HP PTA Balloon Dilatation Catheter | 2023 | 0 |
| K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | 2023 | 0 |
| K212215 | Tiche PTA Balloon Dilatation Catheter | 2022 | 0 |
| K172033 | Pirouette High Pressure (HP) | 2017 | 0 |
| K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | 2016 | 0 |
| K142654 | Fortrex 0.035 OTW PTA Balloon Catheter | 2014 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K113681 (Boston Scientific, 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The Mustang Tm Balloon Dilatation Catheter is indicated for
percutaneous transluminal angioplasty (PTA) in the peripheral vasculature including
iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries, and for the
treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
This catheter is not for use in coronary arteries.
The MustangTm Balloon Dilatation Catheter is also indicated for post-dilatation of
balloon expandable and self-expanding stents in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103751: Mustang Balloon Dilatation Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103751
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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