510(k) · Cleared
ClearedSantreva™-ATK Endovascular Revasculariztion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioSafe, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Sep 22, 2025 as substantially equivalent to K033535 (Lumend, Inc., 2004) after a 59-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Sep 22, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935425 (1994). 10 ancestors in all, the oldest K884647 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 5 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 4 generations backK013284 Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002
- 3 generations backK023114 Lumend Frontrunner Cto CatheterLumend, Inc. · 2003
- 2 generations backK031005 Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003
- 1 generation backK033535 Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
- This deviceK252315 Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −5 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −4 | K013284 | Lumend Frontrunner Cto Coronary Catheter | Lumend, Inc. | 2002 | — |
| −3 | K023114 | Lumend Frontrunner Cto Catheter | Lumend, Inc. | 2003 | — |
| −2 | K031005 | Lumend Frontrunner GW Cto Catheter | Lumend, Inc. | 2003 | — |
| −1 | K033535 | Lumend Frontrunner Cto Catheter and Accessories | Lumend, Inc. | 2004 | — |
| 0 (this device) | K252315 | Santreva™-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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 |
|---|---|---|---|
| * | K033535 | Lumend Frontrunner Cto Catheter and AccessoriesSummary page 5…s catheter (21 CFR 870.1250) Regulatory Class: II Product Code: PDU 3. Predicate Device Predicate Device Name: FRONTRUNNER CTO Catheter, K033535 4. Device Description Santreva™-ATK Endovascular Revascularization Catheter (“Santreva-ATK”) consists of: 1) a distal end me… | 2004 |
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 31 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K033535.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Santreva™-ATK Endovascular Revascularization Catheter is intended to facilitate the intraluminal placement of
guidewires beyond stenotic lesions, including Chronic Total Occlusions (CTOs), in the femoropopliteal (arterial)
peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252315: Santreva™-ATK Endovascular Revasculariztion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252315
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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