510(k) · Cleared
ClearedPossis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C
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 11, 2000 as substantially equivalent to K901627 (Applied Vascular Devices, Inc., 1990) and 1 other predicate after a 1,002-day review. Its family tree reaches back 2 generations to 1990. 4 of the 84 devices in its family, counting itself, have a Class I recall. 81 later devices descend from it.
- Decided
- Apr 11, 2000
- Review
- 1,002 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901627 (1990). 81 later devices descend from it, 6 citing it directly. 4 of the 84 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 1 generation backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- This deviceK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
- Descendant · cites it directly · 70 of its ownK040013 Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray…Possis Medical, Inc. · 2004
- Descendant · 2 generations on · 68 of its ownK052256 Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005
- Descendant · 2 generations on · 66 of its ownK061951 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006
- Descendant · 2 generations on · 63 of its ownK071514 Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc. · 2007
- Descendant · cites it directly · 35 of its ownK073441 Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc. · 2008
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 81 · See all- K040013Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary KitPossis Medical, Inc. · 2004 · cites it directly70descendants
- K052256Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 2005 · 2 generations on68descendants
- K061951Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 2006 · 2 generations on66descendants
- K071514Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307Possis Medical, Inc. · 2007 · 2 generations on63descendants
- K073441Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc. · 2008 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −1 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | 2005 | — |
| +2 | K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | 2006 | — |
| +2 | K071514 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | Possis Medical, Inc. | 2007 | — |
| +1 | K073441 | Angiojet Ultra Avx Thrombectomy Set, Model 105039 | Possis Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 1 |
| 2020 | 2 | 0 |
| 2021 | 6 | 1 |
| 2022 | 2 | 0 |
| 2023 | 9 | 1 |
| 2024 | 3 | 0 |
| 2025 | 5 | 1 |
| 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.
4 devices in this family have 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? (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 |
|---|---|---|---|
| * | K901627 | Arterial Embolectomy CatheterSummary page 5…al Embolectomy Catheter Baxter Healthcare Corp., Edwards U.S. Division (Pre-1976 device) Applied Vascular Arterial Embolectomy Catheter Applied Vascular Devices, Inc. K901627 Possis AngioJet Rapid Thrombectomy Catheters Possis Medical, Inc. K960970 Summary - 1 9055 Evergreen Boulevard NW, Minneapoli… | 1990 |
| * | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140…Summary page 5…-1976 device) Applied Vascular Arterial Embolectomy Catheter Applied Vascular Devices, Inc. K901627 Possis AngioJet Rapid Thrombectomy Catheters Possis Medical, Inc. K960970 Summary - 1 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 phone: 612.780.4555 fax: 612.783.8463 toll free: 800.810.76… | 1996 |
| * | — | Fogarty Arterial Embolectomy Catheter Named without a submission number |
What descends from it? (81)
See all 816 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040013 | Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit | 2004 | 70 |
| K073441 | Angiojet Ultra Avx Thrombectomy Set, Model 105039 | 2008 | 35 |
| K120508 | Clearlumen Thrombectomy System | 2012 | 3 |
| K042874 | Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX) | 2004 | 3 |
| K072769 | Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy Sets | 2007 | 1 |
| K080806 | Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608 | 2008 | 0 |
Has anything in its family been recalled? (4 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.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 7 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K223210ClotTriever XL CatheterInari Medical, Inc. · 2023 · 11 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K040013 (Possis Medical, Inc., 2004) has gone furthest, with 70 descendants of its own.
- 1 other device also cites its predicate K901627.
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 System, with the Catheter, is intended for breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries > 2.0 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/K972610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972610: Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972610
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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