510(k) · Cleared
Recalled · 2007Angiojet DVX Rheolytic Thrombectomy Catheter
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 28, 2005 as substantially equivalent to K040013 (Possis Medical, Inc., 2004) after a 30-day review. Its family tree reaches back 4 generations to 1990. 1 of the 43 devices in its family, counting itself, has a Class I recall. 34 later devices descend from it. It has been recalled once.
- Decided
- Apr 28, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901627 (1990). 8 ancestors in all, the oldest K780551 (1978). 34 later devices descend from it, 1 citing it directly. 1 of the 43 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 3 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 2 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- 1 generation backK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- This deviceK050794 Angiojet DVX Rheolytic Thrombectomy CatheterPossis Medical, Inc. · 2005
- Descendant · cites it directly · 33 of its ownK072269 Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007
- Descendant · 2 generations on · 32 of its ownK090253 Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet…Possis Medical, Inc. · 2009
- Descendant · 2 generations on · 31 of its ownK091593 Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
- Descendant · 3 generations on · 30 of its ownK101406 Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010
- Descendant · 3 generations on · 28 of its ownK111182 Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223210 ClotTriever XL Catheter9 generations on · 2023
Most influential descendants
Showing 5 of 34 · See all- K072269Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc. · 2007 · cites it directly33descendants
- K090253Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior…Possis Medical, Inc. · 2009 · 2 generations on32descendants
- K091593Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009 · 2 generations on31descendants
- K101406Angiojet Solent Proxi Thrombectomy Set Model 109676-001Medrad Interventional/Possis · 2010 · 3 generations on30descendants
- K111182Angiojet Solent Omni Thrombectomy SetMedrad, Inc. · 2011 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −3 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −2 | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140… | Possis Medical, Inc. | 2000 | — |
| −1 | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | Possis Medical, Inc. | 2004 | — |
| 0 (this device) | K050794 | Angiojet DVX Rheolytic Thrombectomy Catheter | Possis Medical, Inc. | 2005 | — |
| +1 | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | Possis Medical, Inc. | 2007 | — |
| +2 | K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior… | Possis Medical, Inc. | 2009 | — |
| +2 | 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 | — |
| +3 | K111182 | Angiojet Solent Omni Thrombectomy Set | Medrad, Inc. | 2011 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 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? (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 |
|---|---|---|---|
| * | K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary KitSummary page 5…ombectomy Catheter Classification 21 CFR 870.5150 Name and No. Embolectomy Catheter —Class 11 Product Code: DXE Predicate Device AngioJet XPEEDIOR® 120 Catheter under K040013 on 5/18/2004. Device Description: The AngioJet DVX Catheter is a 90 cm, 6 French, sterile, single-use catheter designed for rem… | 2004 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | 2007 | 33 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2007 | Not classified | Z-1131-2007 | Other | Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary… |
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 · 9 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K072269 (Possis Medical, Inc., 2007) has gone furthest, with 33 descendants of its own.
- 4 other devices also cite its predicate K040013.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DVX Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries > 3 mm in diameter.
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/K050794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050794: Angiojet DVX Rheolytic Thrombectomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050794
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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