510(k) · Cleared
ClearedEbony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natec Medical, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jun 4, 2015 as substantially equivalent to K112513 (Natec Medical, Ltd., 2011) and 1 other predicate after a 225-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Jun 4, 2015
- Review
- 225 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001134 (2000). 23 ancestors in all, the oldest K971448 (1997). No later device cites it as a predicate yet.
- Root · 7 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 6 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 5 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 4 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 3 generations backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- 2 generations backK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- 1 generation backK112513 Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd. · 2011
- This deviceK143041 Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over…Natec Medical, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −6 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −5 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −4 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −3 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| −2 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| −1 | K112513 | Ebony Pta 0.014 Peripheral Dilatation Catheter | Natec Medical, Ltd. | 2011 | — |
| 0 (this device) | K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire… | Natec Medical, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K112513 | Ebony Pta 0.014 Peripheral Dilatation CatheterSummary page 4…870.1250 Product Code: LIT Device Class: Class II Predicate Devices: Ebony® PTA .014'' RX Peripheral Dilatation Catheter (K112513) Ebony® PTA 0.035 Peripheral Dilatation Catheter (K103354) DEVICE DESCRIPTION The Ebony ® PTA 0.014'' over the wire cathete… | 2011 |
| * | K103354 | Ebony Pta .035 Peripheral Dilatation CatheterSummary page 4…ass: Class II Predicate Devices: Ebony® PTA .014'' RX Peripheral Dilatation Catheter (K112513) Ebony® PTA 0.035 Peripheral Dilatation Catheter (K103354) DEVICE DESCRIPTION The Ebony ® PTA 0.014'' over the wire catheter is a standard catheter with a balloon near the distal tip a… | 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)
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 15 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 23 ancestors have a recall of any class.
- 2 other devices also cite its predicate K112513.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Ebony® PTA 0.014" over the wire Catheter is intended for dilatation of lesions in the femoral, popliteal and infrapopliteal arteries. The Ebony® PTA 0.014" over the wire Catheter is contraindicated for use in coronary arteries or neuro-vasculature.
The Ebony® PTA 0.018" over the wire Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The Ebony® PTA 0.018" over the wire Catheter is not for use in coronary arteries or neuro-vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143041 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143041: Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143041
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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