510(k) · Cleared
Recalled · Class II · 2015Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy Sets
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 Nov 14, 2007 as substantially equivalent to K960970 (Possis Medical, Inc., 1996) and 2 other predicates after a 47-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 14, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K901627 (1990). 1 later device descends from it, 1 citing it directly.
- 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 backK042874 Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX)Possis Medical, Inc. · 2004 · Recalled
- This deviceK072769 Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553)…Possis Medical, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK113363 Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 2012 · cites it directly0descendants
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 | K042874 | Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX) | Possis Medical, Inc. | 2004 | 2 |
| 0 (this device) | K072769 | Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy… | Possis Medical, Inc. | 2007 | — |
| +1 | K113363 | Angiojet Solent Dista Thrombectomy Set | Medrad, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 QEZ? 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? (3)
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 |
|---|---|---|---|
| * | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140…Summary page 7…, XVG®, and Spiroflex® Thrombectomy Set Classification: 870.5150 Product Code: DXE Predicate Device(s): The subject devices are equivalent to the following devices: e K960970 AngioJet Rapid Thrombectomy System — Pump Set e K972610 AngioJet LF140 Catheter e KO042874 AngioJet XMI® Rheolytic Thrombectomy… | 1996 |
| * | K972610 | Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter…Summary page 7…70.5150 Product Code: DXE Predicate Device(s): The subject devices are equivalent to the following devices: e K960970 AngioJet Rapid Thrombectomy System — Pump Set e K972610 AngioJet LF140 Catheter e KO042874 AngioJet XMI® Rheolytic Thrombectomy Catheter e K071342 AngioJet XPEEDIOR® Thrombectomy Set… | 2000 |
| * | K042874 | Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX)Summary page 7…Device(s): The subject devices are equivalent to the following devices: e K960970 AngioJet Rapid Thrombectomy System — Pump Set e K972610 AngioJet LF140 Catheter e KO042874 AngioJet XMI® Rheolytic Thrombectomy Catheter e K071342 AngioJet XPEEDIOR® Thrombectomy Set (reference device-design only) e KO… | 2004 |
| † | K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041… | 2007 |
| † | K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552 | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113363 | Angiojet Solent Dista Thrombectomy Set | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2015 | Class II | Z-2377-2015 | Process control | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K113363 (Medrad, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K960970.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2 mm in diameter.
The AngioJet Ultra XVG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm in diameter.
The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2 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/K072769 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072769: Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072769
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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