510(k) · Cleared
Recalled · Class II · 2018Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brosmed Medical Co., Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 13, 2016 as substantially equivalent to K141118 (Ev3, Inc., 2014) and 2 other predicates after a 253-day review. Its family tree reaches back 11 generations to 2000. It has been recalled once.
- Decided
- Dec 13, 2016
- Review
- 253 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 11 generations to K001134 (2000). 26 ancestors in all, the oldest K993305 (2000). No later device cites it as a predicate yet.
- Root · 11 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 7 generations between
- 3 generations backK130911 Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
- 2 generations backK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
- 1 generation backK141118 Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · Recalled
- This deviceK160941 Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
Show all 11 generations
- Root · 11 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 10 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 9 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 8 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 7 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 6 generations backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- 5 generations backK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · Recalled
- 4 generations backK123544 Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
- 3 generations backK130911 Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
- 2 generations backK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
- 1 generation backK141118 Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · Recalled
- This deviceK160941 Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −10 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −9 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −8 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −7 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −6 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| −5 | K093286 | Powercross .018 Otw Pta Dilation Catheter | Ev3, Inc. | 2009 | 2 |
| −4 | K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| −3 | K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| −2 | K132777 | Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter | Ev3, Inc. | 2013 | — |
| −1 | K141118 | Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter | Ev3, Inc. | 2014 | 1 |
| 0 (this device) | K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K141118 | Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterSummary page 4…catheter (21 CFR 870.1250, Product Code LIT) Predicate Devices: NanoCrossTM Elite 0.014” Over-the-Wire PTA Balloon Dilatation Catheter (K141118; cleared July 18, 2014) SterlingTM Over-the-WireTM (OTW) PTA Balloon Dilatation Catheter… | 2014 |
| * | K132430 | Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterSummary page 4…(K141118; cleared July 18, 2014) SterlingTM Over-the-WireTM (OTW) PTA Balloon Dilatation Catheter (K132430; cleared October 17, 2013) MustangTM Balloon Dilatation Catheter (K103751; cleared March 22, 2011) De… | 2013 |
| * | K103751 | Mustang Balloon Dilatation CathetersSummary page 4…reTM (OTW) PTA Balloon Dilatation Catheter (K132430; cleared October 17, 2013) MustangTM Balloon Dilatation Catheter (K103751; cleared March 22, 2011) Device Description: The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2018 | Class II | Z-0963-2019 | Employee error | Incorrect (higher) Rated Burst Pressure information printed on label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 26 ancestors have a recall of any class.
- 2 other devices also cite its predicate K141118.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160941: Castor, Achilles and Hermes NC 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/K160941
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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