510(k) · Cleared
ClearedSerranator PTA Serration Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cagent Vascular, LLC · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Dec 15, 2021 as substantially equivalent to K163380 (Cagent Vascular, LLC, 2017) after a 19-day review. Its family tree reaches back 12 generations to 1997. 1 later device descends from it.
- Decided
- Dec 15, 2021
- Review
- 19 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K971448 (1997). 44 ancestors in all, the oldest K971010 (1997). 1 later device descends from it, 1 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 backK163380 Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC · 2017
- This deviceK213728 Serranator PTA Serration Balloon CatheterCagent Vascular, LLC · 2021
- Descendant · cites it directly · 0 of its ownK220704 Serranator PTA Serration Balloon CatheterCagent Vascular, LLC · 2022
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 backK163380 Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC · 2017
- This deviceK213728 Serranator PTA Serration Balloon CatheterCagent Vascular, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC · 2022 · 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 | K163380 | Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2017 | — |
| 0 (this device) | K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2021 | — |
| +1 | K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2022 | — |
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 |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K163380 | Serranator Alto PTA Serration Balloon CatheterSummary page 4…FICATION 21CFR 870.1250 REGULATION: DEVICE CLASS: Class II PANEL CODE: PNO PREDICATE DEVICE: K163380 REFERENCE DEVICE: K203437 INTENDED USE/INDICATIONS FOR USE: The Serranator® PTA Serration Balloon Catheter is i… | 2017 |
| † | K203437 | Serranator PTA Serration Balloon Catheter | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220704 | Serranator PTA Serration Balloon Catheter | 2022 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 44 ancestors have a recall of any class.
- Of its descendants, K220704 (Cagent Vascular, LLC, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, and
popliteal arteries 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/K213728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213728: Serranator PTA Serration 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/K213728
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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