510(k) · Cleared
ClearedEbony Pta .035 Peripheral Dilatation 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 Feb 23, 2011 as substantially equivalent to K062809 (Invatec Innovative Technologies, 2006) after a 99-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Feb 23, 2011
- Review
- 99 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042538 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK042538 Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 1 generation backK062809 Admiral Xtreme Pta CatheterInvatec Innovative Technologies · 2006
- This deviceK103354 Ebony Pta .035 Peripheral Dilatation CatheterNatec Medical, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK143041 Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over…Natec Medical, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK143036 Ebony PTA 0.035 Peripheral Dilatation CatheterNatec Medical, Ltd. · 2015
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 |
|---|---|---|---|---|---|
| −2 | K042538 | Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −1 | K062809 | Admiral Xtreme Pta Catheter | Invatec Innovative Technologies | 2006 | — |
| 0 (this device) | K103354 | Ebony Pta .035 Peripheral Dilatation Catheter | Natec Medical, Ltd. | 2011 | — |
| +1 | K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire… | Natec Medical, Ltd. | 2015 | — |
| +1 | K143036 | Ebony PTA 0.035 Peripheral Dilatation Catheter | Natec Medical, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K062809 | Admiral Xtreme Pta CatheterSummary page 1…807.92(a)(3) Legally Marketed Equivalent Device I KNumber I Trade Name Manufacturer K062809 ADMIRAL XTREME' PTA Invatec Innovative Catheter… | 2006 |
What descends from it? (2)
2 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143041 (Natec Medical, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K062809.
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 Ebony" .035 PTA Catheter is intended for the dilation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries.
The EbonyO .035 PTA Catheter is not for use in coronary arteries or neuro-vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103354: Ebony Pta .035 Peripheral 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/K103354
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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