510(k) · Cleared
ClearedAngiosculpt Pta Scoring Balloon with Hydrocross Caoting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angioscore, Inc. · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Apr 18, 2014 as substantially equivalent to K112182 (Angioscore, Inc., 2011) and 2 other predicates after a 113-day review. Its family tree reaches back 11 generations to 1997. 24 later devices descend from it.
- Decided
- Apr 18, 2014
- Review
- 113 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K971448 (1997). 43 ancestors in all, the oldest K971010 (1997). 24 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 7 generations between
- 3 generations backK110767 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 2 generations backK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 1 generation backK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- This deviceK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
- Descendant · cites it directly · 16 of its ownK142983 AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc. · 2015
- Descendant · 2 generations on · 13 of its ownK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- Descendant · 3 generations on · 10 of its ownK163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty…Shockwave Medical, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK150634 AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015
- Descendant · 4 generations on · 4 of its ownK180958 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter…Shockwave Medical, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
- 10 generations backK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
- 9 generations backK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
- 8 generations backK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
- 7 generations backK080151 Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · Recalled
- 6 generations backK081220 Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008
- 5 generations backK091966 Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040…Angioscore, Inc. · 2009
- 4 generations backK100303 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc. · 2010
- 3 generations backK110767 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 2 generations backK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
- 1 generation backK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
- This deviceK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc. · 2015 · cites it directly16descendants
- K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc. · 2016 · 2 generations on13descendants
- K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc. · 2016 · 3 generations on10descendants
- K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics · 2015 · cites it directly6descendants
- K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc. · 2018 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971448 | Cordis Opta LP Pta Balloon Catheter | Cordis Corp. | 1997 | — |
| −10 | K013581 | Cordis Aviator Peripheral Dilatation Catheter | Cordis, A Johnson & Johnson Co. | 2001 | — |
| −9 | K050629 | Angiosculpt Scoring Balloon Catheter | Angioscore, Inc. | 2005 | — |
| −8 | K072225 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2007 | 5 |
| −7 | K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 | Angioscore, Inc. | 2008 | 5 |
| −6 | K081220 | Modification to Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2008 | — |
| −5 | K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040 | Angioscore, Inc. | 2009 | — |
| −4 | K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy… | Angioscore, Inc. | 2010 | — |
| −3 | K110767 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| −2 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
| −1 | K122685 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2013 | — |
| 0 (this device) | K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross Caoting | Angioscore, Inc. | 2014 | — |
| +1 | K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Angioscore, Inc. | 2015 | — |
| +2 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and… | Shockwave Medical, Inc. | 2016 | — |
| +3 | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And… | Shockwave Medical, Inc. | 2016 | — |
| +1 | K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | 2015 | — |
| +4 | K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter… | Shockwave Medical, Inc. | 2018 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (3)
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 |
|---|---|---|---|
| * | K112182 | Angiosculpt Pta Scoring Balloon CatheterSummary page 4…sty catheter Classification Name: Percutaneous catheter Product Code: LT Regulation Number: 21 CFR 870.1250 Predicate Devices: AngioSculpt® Scoring Balloon Catheter (K112182/K122685) VascuTrak® PTA Dilatation Catheter (K013459) intended Use / Indications The AngioSculpt PTA Scoring Balloon Catheter i… | 2011 |
| * | K122685 | Angiosculpt Pta Scoring Balloon CatheterSummary page 4…eter Classification Name: Percutaneous catheter Product Code: LT Regulation Number: 21 CFR 870.1250 Predicate Devices: AngioSculpt® Scoring Balloon Catheter (K112182/K122685) VascuTrak® PTA Dilatation Catheter (K013459) intended Use / Indications The AngioSculpt PTA Scoring Balloon Catheter is intend… | 2013 |
| * | K103459 | Vascutrak Pta Dilatation Catheter Our OCR of the scanned summary read K013459, FDA’s number for Modification of NC-Stat (Neurometrix, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “VascuTrak® PTA Dilatation Catheter”. | 2010 |
What descends from it? (24)
See all 242 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 17 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 43 ancestors have a recall of any class.
- Of its descendants, K142983 (Angioscore, Inc., 2015) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K112182.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The AngioSculpt PTA Scoring Balloon Catheter I8 intended for dilatation of lesions in the ‘lliac, femoral, ilto-femnoral, popliteal, infra poptiteal, and renal arteries, and for the treatment of obstructive leslons of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or néuro-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/K133998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133998: Angiosculpt Pta Scoring Balloon with Hydrocross Caoting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133998
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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