510(k) · Cleared
ClearedWAVE PTA Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
WAVE Medical AG · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on May 20, 2026 as substantially equivalent to K102705 (Abbott Vascular, Inc., 2010) after a 110-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- May 20, 2026
- Review
- 110 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001134 (2000). 26 ancestors in all, the oldest K970299 (1997). No later device cites it as a predicate yet.
- Root · 8 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 7 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 6 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 5 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 4 generations backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- 3 generations backK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- 2 generations backK072798 Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions · 2008 · Recalled
- 1 generation backK102705 Armada 14 Pta CatheterAbbott Vascular, Inc. · 2010
- This deviceK260304 WAVE PTA Balloon CatheterWAVE Medical AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −7 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −6 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −5 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −4 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| −3 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| −2 | K072798 | Viatrac 14 Plus Peripheral Dilation Catheter | Abbott Vascular-Vascular Solutions | 2008 | 1 |
| −1 | K102705 | Armada 14 Pta Catheter | Abbott Vascular, Inc. | 2010 | — |
| 0 (this device) | K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K102705 | Armada 14 Pta CatheterSummary page 5…e Name: Armada 14 PTA Catheter Manufacturer: Abbott Vascular 510(k) Clearance: K102705 Classification Regulation: 21 CFR, Part 870.1250 Classification Name: P… | 2010 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 26 ancestors have a recall of any class.
- 3 other devices also cite its predicate K102705.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 WAVE PTA Balloon Catheter is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260304: WAVE PTA Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260304
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026