510(k) · Cleared
ClearedZelanteDVT Thrombectomy Set
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 Sep 21, 2015 as substantially equivalent to K111182 (Medrad, Inc., 2011) after a 126-day review. Its family tree reaches back 12 generations to 1990. 1 of the 48 devices in its family, counting itself, has a Class I recall. 26 later devices descend from it.
- Decided
- Sep 21, 2015
- Review
- 126 days
- Class
- Class II
- Product code
- QEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K901627 (1990). 21 ancestors in all, the oldest K780551 (1978). 26 later devices descend from it, 2 citing it directly. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 8 generations between
- 3 generations backK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- 2 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 1 generation backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- This deviceK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- Descendant · cites it directly · 21 of its ownK193462 ClotTriever Thrombectomy SystemInari Medical · 2020
- Descendant · 2 generations on · 20 of its ownK210190 ClotTriever Thrombectomy SystemIrani Medical, Inc. · 2021
- Descendant · 3 generations on · 19 of its ownK210689 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- Descendant · 4 generations on · 15 of its ownK212632 ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021
- Descendant · 5 generations on · 3 of its ownK223000 Artix BGInari Medical · 2023
Show all 12 generations
- Root · 12 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 11 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 10 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 9 generations backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- 8 generations backK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- 7 generations backK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- 6 generations backK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- 5 generations backK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- 4 generations backK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- 3 generations backK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- 2 generations backK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- 1 generation backK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- This deviceK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223210 ClotTriever XL Catheter5 generations on · 2023
Most influential descendants
Showing 5 of 26 · See all- K193462ClotTriever Thrombectomy SystemInari Medical · 2020 · cites it directly21descendants
- K210190ClotTriever Thrombectomy SystemIrani Medical, Inc. · 2021 · 2 generations on20descendants
- K210689ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021 · 3 generations on19descendants
- K212632ClotTriever Thrombectomy SystemInari Medical, Inc. · 2021 · 4 generations on15descendants
- K223000Artix BGInari Medical · 2023 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −11 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −10 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −9 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| −8 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| −7 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| −6 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| −5 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| −4 | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| −3 | K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets | Possis Medical, Inc. | 2009 | — |
| −2 | K101406 | Angiojet Solent Proxi Thrombectomy Set Model 109676-001 | Medrad Interventional/Possis | 2010 | — |
| −1 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
| 0 (this device) | K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015 | — |
| +1 | K193462 | ClotTriever Thrombectomy System | Inari Medical | 2020 | — |
| +2 | K210190 | ClotTriever Thrombectomy System | Irani Medical, Inc. | 2021 | — |
| +3 | K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| +4 | K212632 | ClotTriever Thrombectomy System | Inari Medical, Inc. | 2021 | — |
| +5 | K223000 | Artix BG | Inari Medical | 2023 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 9 | 1 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K111182 | Angiojet Solent Omni Thrombectomy SetSummary page 4…(Catheter, Continuous Flush) Code Classification of Device Class 2 according to 21 CFR 870.5150 Predicate Device(s) Solent™ Omni Thrombectomy Set K111182 24 May 2011 Device Description The ZelanteDVT™ Thrombectomy Set is one component of the AngioJet® Ultra Thrombectomy Sys… | 2011 |
What descends from it? (26)
See all 262 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223210ClotTriever XL CatheterInari Medical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K193462 (Inari Medical, 2020) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K111182.
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. 2015, 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 Set is intended for use with the AngioJet® Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
• Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
• Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy Set 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 as stated in the FDA summary.
https://510kreport.com/device/K151313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151313: ZelanteDVT Thrombectomy Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151313
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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