510(k) · Cleared
ClearedAngiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Possis Medical, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Apr 8, 2009 as substantially equivalent to K082382 (Possis Medical, Inc., 2008) and 6 other predicates after a 65-day review. Its family tree reaches back 8 generations to 1990. 1 of the 50 devices in its family, counting itself, has a Class I recall. 32 later devices descend from it.
- Decided
- Apr 8, 2009
- Review
- 65 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K901627 (1990). 17 ancestors in all, the oldest K780551 (1978). 32 later devices descend from it, 1 citing it directly. 1 of the 50 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 7 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 6 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 5 generations backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- 4 generations backK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- 3 generations backK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- 2 generations backK071342 Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042…Possis Medical, Inc. · 2007
- 1 generation backK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- This deviceK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- Descendant · cites it directly · 31 of its ownK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- Descendant · 2 generations on · 30 of its ownK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- Descendant · 2 generations on · 28 of its ownK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 26 of its ownK151313 ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015
- Descendant · 4 generations on · 21 of its ownK193462 ClotTriever Thrombectomy SystemInari Medical · 2020
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223210 ClotTriever XL Catheter8 generations on · 2023
Most influential descendants
Showing 5 of 32 · See all- K091593Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009 · cites it directly31descendants
- K101406Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010 · 2 generations on30descendants
- K111182Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · 2 generations on28descendants
- K151313ZelanteDVT Thrombectomy SetBoston Scientific Corporation · 2015 · 3 generations on26descendants
- K193462ClotTriever Thrombectomy SystemInari Medical · 2020 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −7 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −6 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −5 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| −4 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| −3 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| −2 | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552… | Possis Medical, Inc. | 2007 | — |
| −1 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| 0 (this device) | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| +1 | 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 | — |
| +2 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
| +3 | K151313 | ZelanteDVT Thrombectomy Set | Boston Scientific Corporation | 2015 | — |
| +4 | K193462 | ClotTriever Thrombectomy System | Inari Medical | 2020 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 QEZ device
- #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 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? (7)
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 |
|---|---|---|---|
| * | K082382 | Angiojet Ultra Avx Thrombectomy Set, Model 105039Summary page 6…omy Catheter - Angiolet® Ultra DVX® Thrombectomy Set and AngioJet® Ultra Xpeedior® Thrombectomy Set Embolectomy Catheter AngioJet AVX Thrombectomy Set with injection (K082382) AngioJet Ultra DVX Thrombectomy Set (K072269) AngioJet Ultra Xpeedior Thrombectomy Set (K071342) AngioJet Xpeedior Rheolytic Thr… | 2008 |
| * | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552Summary page 6…omy Set and AngioJet® Ultra Xpeedior® Thrombectomy Set Embolectomy Catheter AngioJet AVX Thrombectomy Set with injection (K082382) AngioJet Ultra DVX Thrombectomy Set (K072269) AngioJet Ultra Xpeedior Thrombectomy Set (K071342) AngioJet Xpeedior Rheolytic Thrombectomy Catheter (K071336) AngioJet Xpeedio… | 2007 |
| * | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041…Summary page 6…Set Embolectomy Catheter AngioJet AVX Thrombectomy Set with injection (K082382) AngioJet Ultra DVX Thrombectomy Set (K072269) AngioJet Ultra Xpeedior Thrombectomy Set (K071342) AngioJet Xpeedior Rheolytic Thrombectomy Catheter (K071336) AngioJet Xpeedior Rheolytic Thrombectomy Catheter (KO71514) Angio… | 2007 |
| * | K071336 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Summary page 6…h injection (K082382) AngioJet Ultra DVX Thrombectomy Set (K072269) AngioJet Ultra Xpeedior Thrombectomy Set (K071342) AngioJet Xpeedior Rheolytic Thrombectomy Catheter (K071336) AngioJet Xpeedior Rheolytic Thrombectomy Catheter (KO71514) AngioJet Xpeedior Catheter (K993564) AngioJet LF 140 Catheter (K9… | 2007 |
| * | K071514 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | 2007 |
| * | K993564 | Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002Summary page 6…tomy Set (K071342) AngioJet Xpeedior Rheolytic Thrombectomy Catheter (K071336) AngioJet Xpeedior Rheolytic Thrombectomy Catheter (KO71514) AngioJet Xpeedior Catheter (K993564) AngioJet LF 140 Catheter (K960970) AngiolJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets… | 2000 |
| * | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140…Summary page 6…r Rheolytic Thrombectomy Catheter (K071336) AngioJet Xpeedior Rheolytic Thrombectomy Catheter (KO71514) AngioJet Xpeedior Catheter (K993564) AngioJet LF 140 Catheter (K960970) AngiolJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include the AngioJet DVX and X… | 1996 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy Sets | 2009 | 31 |
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 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K091593 (Possis Medical, Inc., 2009) has gone furthest, with 31 descendants of its own.
- 1 other device also cites its predicate K082382.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · QEZ
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEZ
No recall names QEZ since 2007.
Adverse event reports per year · QEZ
21in 2025
MAUDE reports naming product code QEZ, 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 | 11 | 79 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 4 | 83 | 0 | 0 |
| 2010 | 3 | 33 | 0 | 0 |
| 2011 | 7 | 118 | 0 | 0 |
| 2012 | 5 | 90 | 0 | 0 |
| 2013 | 4 | 144 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 94 | 0 | 0 |
| 2020 | 3 | 120 | 0 | 0 |
| 2021 | 3 | 53 | 0 | 2 |
| 2022 | 2 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 5 | 108 | 0 | 21 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from * Upper and Lower extremity peripheral arteries > 3 mm in diameter * Upper extremity peripheral veins > 3 mm in diameter Ileofemoral and lower extremity veins > 3 mm in diameter * AV access conduits > 3 mm in diameter and For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician…
Read the full statement (184 words)
The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from
* Upper and Lower extremity peripheral arteries > 3 mm in diameter
* Upper extremity peripheral veins > 3 mm in diameter
Ileofemoral and lower extremity veins > 3 mm in diameter
* AV access conduits > 3 mm in diameter and
For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from
* Upper and Lower extremity peripheral arteries > 3 mm in diameter
* Upper extremity peripheral veins > 3 mm in diameter
* Ileofemoral and lower extremity veins > 3 mm in diameter
* AV access conduits > 3 mm in diameter and
* For use with the AngioJet Ultra Power Pulse Kit for the control 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/K090253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090253: Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090253
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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