510(k) · Cleared
Recalled · Class II · 2019PolarCath Peripheral Dilatation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucyro Vascular, LLC · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Oct 26, 2015 as substantially equivalent to K092455 (Boston Scientific Corporation, 2009) after a 39-day review. Its family tree reaches back 1 generation to 2009. It has been recalled once.
- Decided
- Oct 26, 2015
- Review
- 39 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092455 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK092455 Modification to: Polarcath Peripheral Dilatation SystemBoston Scientific Corporation · 2009
- This deviceK152665 PolarCath Peripheral Dilatation SystemNucyro Vascular, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092455 | Modification to: Polarcath Peripheral Dilatation System | Boston Scientific Corporation | 2009 | — |
| 0 (this device) | K152665 | PolarCath Peripheral Dilatation System | Nucyro Vascular, LLC | 2015 | — |
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 |
|---|---|---|---|
| * | K092455 | Modification to: Polarcath Peripheral Dilatation SystemSummary page 5…e 5 === Page 2 of 3 PREDICATE DEVICE(S) PolarCath Peripheral Dilatation System (K092455) This predicate has not been subject to a design-related recall. INDICATIONS FOR USE The PolarCath Peripheral Dilatation System… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2019 | Class II | Z-0507-2020 | Error in labeling | Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular 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/K152665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152665: PolarCath Peripheral Dilatation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152665
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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