510(k) · Cleared
ClearedAngioSculpt PTA Scoring Baloon Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetrics · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Apr 8, 2015 as substantially equivalent to K133998 (Angioscore, Inc., 2014) and 1 other predicate after a 28-day review. Its family tree reaches back 12 generations to 1997. 6 later devices descend from it.
- Decided
- Apr 8, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K971448 (1997). 44 ancestors in all, the oldest K971010 (1997). 6 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 8 generations between
- 3 generations backK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 2 generations backK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- 1 generation backK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
- This deviceK150634 AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015
- Descendant · cites it directly · 2 of its ownK193495 XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific · 2020
- Descendant · cites it directly · 1 of its ownK232013 Aperta NSE PTA Balloon Dilatation Catheter…Goodman Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK221986 XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter…Transit Scientific, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK243944 Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241478 Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 11 generations backK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
- 10 generations backK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
- 9 generations backK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
- 8 generations backK080151 Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · Recalled
- 7 generations backK081220 Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008
- 6 generations backK091966 Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040…Angioscore, Inc. · 2009
- 5 generations backK100303 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc. · 2010
- 4 generations backK110767 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 3 generations backK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 2 generations backK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- 1 generation backK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
- This deviceK150634 AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific · 2020 · cites it directly2descendants
- K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd. · 2024 · cites it directly1descendant
- K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC · 2022 · 2 generations on1descendant
- K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd. · 2025 · 2 generations on0descendants
- K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K971448 | Cordis Opta LP Pta Balloon Catheter | Cordis Corp. | 1997 | — |
| −11 | K013581 | Cordis Aviator Peripheral Dilatation Catheter | Cordis, A Johnson & Johnson Co. | 2001 | — |
| −10 | K050629 | Angiosculpt Scoring Balloon Catheter | Angioscore, Inc. | 2005 | — |
| −9 | K072225 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2007 | 5 |
| −8 | K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | Angioscore, Inc. | 2008 | 5 |
| −7 | K081220 | Modification to Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2008 | — |
| −6 | K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040 | Angioscore, Inc. | 2009 | — |
| −5 | K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy… | Angioscore, Inc. | 2010 | — |
| −4 | K110767 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| −3 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| −2 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | — |
| −1 | K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross Caoting | Angioscore, Inc. | 2014 | — |
| 0 (this device) | K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | 2015 | — |
| +1 | K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | 2020 | — |
| +1 | K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040… | Goodman Co., Ltd. | 2024 | — |
| +2 | K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score… | Transit Scientific, LLC | 2022 | — |
| +2 | K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 2025 | — |
| +1 | K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 PNO? 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 PNO device
- #1 K261778 JADE SCORE PTA Scoring Balloon Dilatation…score 14.1 · 8 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 |
|---|---|---|---|
| * | K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross CaotingSummary page 4…culpt PTA Scoring Balloon Catheter was compared to the following legally marketed predicate device: Trade Name/510(k) Number: AngioSculpt® PTA Scoring Balloon Catheters K133998 4.0-6.0x200mm (137cm length) Manufacturer: Spectranetics Device Common Name: Angioplasty catheter Trade Name/510(k) Number Ang… | 2014 |
| * | K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040Summary page 4…4.0-6.0x200mm (137cm length) Manufacturer: Spectranetics Device Common Name: Angioplasty catheter Trade Name/510(k) Number AngioSculpt® PTA Scoring Balloon Catheters K091966 6.0x40mm (50,90 and 137cm) Manufacturer: Spectranetics Device Common Name Angioplasty catheter The Spectranetics Corporation 9… | 2009 |
What descends from it? (6)
3 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 18 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 44 ancestors have a recall of any class.
- Of its descendants, K193495 (Transit Scientific, 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K133998.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PNO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNO
246in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNO
No recall names PNO since 2007.
Adverse event reports per year · PNO
511in 2025
MAUDE reports naming product code PNO, 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 | 3 | 61 | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 23 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 84 | 0 | 0 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 3 | 74 | 0 | 26 |
| 2018 | 0 | — | 0 | 55 |
| 2019 | 1 | — | 0 | 81 |
| 2020 | 4 | 94 | 0 | 121 |
| 2021 | 1 | — | 0 | 90 |
| 2022 | 2 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 4 | 246 | 0 | 537 |
| 2025 | 2 | — | 0 | 511 |
| 2026 | 3 | 110 | 0 | — |
What is it indicated for?
For dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
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/K150634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150634: AngioSculpt PTA Scoring Baloon Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150634
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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