510(k) · Cleared
ClearedPasseo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 4, 2025 as substantially equivalent to K222065 (Biotronik, Inc., 2023) and 4 other predicates after a 25-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Apr 4, 2025
- Review
- 25 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K001134 (2000). 27 ancestors in all, the oldest P790017 (1980). No later device cites it as a predicate yet.
- Root · 9 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations between
- 3 generations backK192399 Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC · 2020
- 2 generations backK214038 Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. · 2022
- 1 generation backK241711 Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. · 2024
- This deviceK250706 Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral…Biotronik, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 8 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 7 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 6 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 5 generations backK132430 Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterBoston Scientific Corp · 2013
- 4 generations backK141112 Sterling Over-the Wire Pta Balloon Dilatation CatheterBoston Scientific · 2014
- 3 generations backK192399 Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC · 2020
- 2 generations backK214038 Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. · 2022
- 1 generation backK241711 Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. · 2024
- This deviceK250706 Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral…Biotronik, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −8 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −7 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −6 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −5 | K132430 | Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2013 | — |
| −4 | K141112 | Sterling Over-the Wire Pta Balloon Dilatation Catheter | Boston Scientific | 2014 | — |
| −3 | K192399 | Infinity Angioplasty Balloon Catheter | Infinity Angioplasty Balloon Company, LLC | 2020 | — |
| −2 | K214038 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2022 | — |
| −1 | K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2024 | — |
| 0 (this device) | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation… | Biotronik, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K222065 | Passeo-35 Xeo Peripheral Dilatation CatheterSummary page 10…Type: Catheter, angioplasty, peripheral, transluminal Product Code: LIT Regulation Number 870.1250 Predicate Device: Passeo-35 Xeo (K222065) Device Description BIOTRONIK’s Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for di… | 2023 |
| * | K151744 | Passeo-18 Peripheral Dilation CatheterSummary page 15…Type: Catheter, angioplasty, peripheral, transluminal Product Code: LIT Regulation Number 870.1250 Predicate Device: Passeo-18 (K151744) Device Description The Passeo-18 peripheral dilatation catheter is intended for dilatation of stenotic segments in peripheral… | 2015 |
| * | K152240 | Passeo-14 Peripheral Dilatation CatheterSummary page 21…Type: Catheter, angioplasty, peripheral, transluminal Product Code: LIT Regulation Numbers 870.1250 Predicate Device: Passeo-14 (K152240) Device Description The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic segments in lower… | 2015 |
| * | K241711 | Oscar Peripheral Multifunctional Catheter systemSummary page 26…gioplasty, peripheral, transluminal Product Code: LIT (Primary), KRA (Secondary) Regulation Number 870.1250, 870.1210 Predicate Device: Oscar (K241711) Device Description The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied… | 2024 |
| * | K242969 | Pantera Pro; Pantera LEOSummary page 31…Catheter, transluminal coronary angioplasty, percutaneous Product Code: LOX Regulation Number 870.5100 Predicate Device: Pantera LEO (K242969) Device Description Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port… | 2024 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 27 ancestors have a recall of any class.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in…
Read the full statement (230 words)
The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Passeo-14 1s indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.
The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries.
The product is also intended for injection of radiopaque contrast media for the purpose of angiography.
The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.
The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 — 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250706: Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250706
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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