510(k) Report

510(k) · Cleared

Cleared

Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608

K080806510(k) TraditionalCleared Apr 4, 200814-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Possis Medical, Inc. · QEZ Aspiration Thrombectomy Catheter

Cleared on Apr 4, 2008 as substantially equivalent to K960970 (Possis Medical, Inc., 1996) and 2 other predicates after a 14-day review. Its family tree reaches back 4 generations to 1990.

Decided
Apr 4, 2008
Review
14 days
Class
Class II
Product code
QEZ
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K901627 (1990). No later device cites it as a predicate yet.

Reference device: K071342 · Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039 · Possis Medical, Inc. · 2007Reference device: K072269 · Angiojet Ultra DVX Thrombectomy Set, Model: 106552 · Possis Medical, Inc. · 2007Reference device: K072769 · Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy Sets · Possis Medical, Inc. · 2007 · recalledReference device: K073441 · Angiojet Ultra Avx Thrombectomy Set, Model 105039 · Possis Medical, Inc. · 2008K901627 · Arterial Embolectomy Catheter · Applied Vascular Devices, Inc. · 1990 · recalledK960970 · Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P · Possis Medical, Inc. · 1996K972610 · Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C · Possis Medical, Inc. · 2000K042874 · Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX) · Possis Medical, Inc. · 2004 · recalled19901995200020052010
K042874 · Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX) · Possis Medical, Inc. · 2004 · recalledK972610 · Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C · Possis Medical, Inc. · 2000K960970 · Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P · Possis Medical, Inc. · 1996K901627 · Arterial Embolectomy Catheter · Applied Vascular Devices, Inc. · 1990 · recalled0
  1. Root · 4 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
  2. 3 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
  3. 2 generations backK972610 Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model…Possis Medical, Inc. · 2000
  4. 1 generation backK042874 Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX)Possis Medical, Inc. · 2004 · Recalled
  5. This deviceK080806 Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608Possis Medical, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K901627Arterial Embolectomy CatheterApplied Vascular Devices, Inc.19901
−3K960970Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model…Possis Medical, Inc.1996—
−2K972610Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140…Possis Medical, Inc.2000—
−1K042874Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX)Possis Medical, Inc.20042
0 (this device)K080806Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608Possis Medical, Inc.2008—
FIG. 1 — Lineage of K080806, 1990–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253925 Aventus Thrombectomy Systemscore 17.9 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K960970Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140…
Summary page 5
…ail: [email protected] March 20, 2008 Angiolet® Ultra Spiroflex® VG Thrombectomy Set 870.5150 DXE The subject devices are equivalent to the following devices: s K960970 AngioJet Rapid Thrombectomy System ~ Pump Set e K972610 AngioJet LF140 Catheter e K042874 AngioJet XMI-RX Thrombectomy Catheter »…
Possis Medical, Inc.1996—
*K972610Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter…
Summary page 5
…Ultra Spiroflex® VG Thrombectomy Set 870.5150 DXE The subject devices are equivalent to the following devices: s K960970 AngioJet Rapid Thrombectomy System ~ Pump Set e K972610 AngioJet LF140 Catheter e K042874 AngioJet XMI-RX Thrombectomy Catheter » K071342 AngioJet XPEEDIOR® Thrombectomy Set (reference…
Possis Medical, Inc.2000—
*K042874Angiojet Xmi Catheter - Rapid Exchange (Xmi-RX)
Summary page 5
…et 870.5150 DXE The subject devices are equivalent to the following devices: s K960970 AngioJet Rapid Thrombectomy System ~ Pump Set e K972610 AngioJet LF140 Catheter e K042874 AngioJet XMI-RX Thrombectomy Catheter » K071342 AngioJet XPEEDIOR® Thrombectomy Set (reference device-design only) e KO072269 Ang…
Possis Medical, Inc.20042
†K071342Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041…Possis Medical, Inc.2007—
†K072269Angiojet Ultra DVX Thrombectomy Set, Model: 106552Possis Medical, Inc.2007—
†K072769Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy SetsPossis Medical, Inc.20071
†K073441Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc.2008—

Also cleared against K960970: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 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.
  • 6 other devices also cite its predicate K960970.

How does its category compare?

All QEZ devices

QEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · QEZ

5in 2025

2007: 112008: 62009: 42010: 32011: 72012: 52013: 42014: 12016: 12017: 32018: 12019: 32020: 32021: 32022: 22023: 12024: 12025: 52026 (partial year): 6
2007high 11 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEZ

108in 2025

2007: 79 days median2008: 72 days median2009: 83 days median2010: 33 days median2011: 118 days median2012: 90 days median2013: 144 days median2017: 112 days median2019: 94 days median2020: 120 days median2021: 53 days median2025: 108 days median2026 (partial year): 98 days median
2007high 144 (2013) · low 33 (2010)2026

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

2021: 22022: 182023: 142024: 172025: 21
2007high 21 (2025) · low 0 (2007)2025

MAUDE reports naming product code QEZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007117900
200867200
200948300
201033300
2011711800
201259000
2013414400
20141—00
20150—00
20161—00
2017311200
20181—00
201939400
2020312000
202135302
20222—018
20231—014
20241—017
20255108021
20266980—

What is it indicated for?

The AngioJet Ultra Spiroflex VG 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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K960970

6 other devices cite the same predicate.

  • K090253Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model…Possis Medical, Inc. · 2009
  • K073441Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc. · 2008
  • K072769Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy SetsPossis Medical, Inc. · 20071 recall
  • K021096X-Sizer Catheter SystemEv3 Corporation · 20042 recalls
  • K013473XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model # CT0006001; XTD Collection…Xtrak Medical, Inc. · 2002
  • K972610Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040CPossis Medical, Inc. · 2000

More from Possis Medical, Inc.

36 FDA decisions under this applicant name. See the company

  • K133629Angiojet Ultra Avx Thrombectomy SetPossis Medical, Inc. · 20141 recall
  • K091593Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
  • K090253Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model…Possis Medical, Inc. · 2009
  • K082382Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc. · 2008
  • K081989Modification to Fetch Aspiration CatheterPossis Medical, Inc. · 2008

Recent decisions in QEZ

The QEZ category page

  • K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo Neuro · 2026
  • K261105Powered Aventus Thrombectomy System™Inquis Medical · 2026
  • K262030Aventus Thrombectomy SystemInquis Medical · 2026
  • K253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc. · 2026
  • K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc. · 2026

https://510kreport.com/device/K080806 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080806: Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080806

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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