510(k) · Cleared
ClearedZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Oct 2, 2020 as substantially equivalent to K151313 (Boston Scientific Corporation, 2015) after a 57-day review. Its family tree reaches back 13 generations to 1990. 3 later devices descend from it.
- Decided
- Oct 2, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K901627 (1990). 22 ancestors in all, the oldest K780551 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 9 generations between
- 3 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 2 generations backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- 1 generation backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- This deviceK202218 ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical…Boston Scientific Corporation · 2020
- Descendant · cites it directly · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253730 RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243549 JETi Hydrodynamic Thrombectomy SystemAbbott Medical · 2025
Show all 13 generations
- Root · 13 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 12 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 11 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 10 generations backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- 9 generations backK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- 8 generations backK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- 7 generations backK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- 6 generations backK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- 5 generations backK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- 4 generations backK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- 3 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 2 generations backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- 1 generation backK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- This deviceK202218 ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical…Boston Scientific Corporation · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −12 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −11 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −10 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| −9 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| −8 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| −7 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| −6 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| −5 | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| −4 | K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets | Possis Medical, Inc. | 2009 | — |
| −3 | K101406 | Angiojet Solent Proxi Thrombectomy Set Model 109676-001 | Medrad Interventional/Possis | 2010 | — |
| −2 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
| −1 | K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015 | — |
| 0 (this device) | K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device | Boston Scientific Corporation | 2020 | — |
| +1 | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +2 | K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026 | — |
| +1 | K243549 | JETi Hydrodynamic Thrombectomy System | Abbott Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 QEW? 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 QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 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 |
|---|---|---|---|
| * | K151313 | ZelanteDVT Thrombectomy SetSummary page 4…; Catheter, Continuous Flush Product Code QEW, KRA Classification Class II, 21 CFR Part 870.5150 Predicate Device ZelanteDVT Thrombectomy Set (K151313), cleared 21 September 2015 Reference Device Amplatz Super Stiff Guidewire (K843012), cleared 29 November 1984 Device Des… | 2015 |
| † | K843012 | Wireguide or Guidewire | 1984 |
What descends from it? (3)
2 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 30 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K220780 (2mg, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K151313.
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The ZelanteDVT Thrombectomy System, which includes the ZelanteDVT Thrombectomy Set and the ClotHunter Helical Rotation Device, is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
liofemoral and lower extremity veins > 6.0 mm in diameter and
Upper extremity peripheral veins > 6.0 mm in diameter.
The ZelanteDVT Thrombectomy System is also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
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/K202218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202218: ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202218
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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