510(k) Report

510(k) · Cleared

Recalled · 2010

Quickcat Extraction Catheter, Model 60090-01

K073519510(k) SpecialCleared Mar 28, 2008105-day reviewClass II21 CFR 870.5150Recalls 1

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

Kensey Nash Corp. · QEZ Aspiration Thrombectomy Catheter

Cleared on Mar 28, 2008 as substantially equivalent to K060092 (Kensey Nash Corp., 2006) after a 105-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it. It has been recalled once.

Decided
Mar 28, 2008
Review
105 days
Class
Class II
Product code
QEZ
Recalls
1
Predicates
1

Its longest line of descent runs back 4 generations to K010579 (2001). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2003: 1 other ancestor2004: 1 other ancestor2002: 3 other ancestors2009: 1 descendant clearedK010579 · Stent Support Guide Catheter · Medtronic Vascular · 2001 · recalledK030201 · Modification to Export Aspiration Catheter · Medtronic Vascular · 2003K040869 · Export Catheter · Medtronic Vascular · 2004K060092 · Quickcat Extraction Catheter · Kensey Nash Corp. · 2006 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 3 other ancestors 1 generation forward: 1 descendant K060092 · Quickcat Extraction Catheter · Kensey Nash Corp. · 2006 · recalledK040869 · Export Catheter · Medtronic Vascular · 2004K030201 · Modification to Export Aspiration Catheter · Medtronic Vascular · 2003K010579 · Stent Support Guide Catheter · Medtronic Vascular · 2001 · recalled0
  1. Root · 4 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
  2. 3 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
  3. 2 generations backK040869 Export CatheterMedtronic Vascular · 2004
  4. 1 generation backK060092 Quickcat Extraction CatheterKensey Nash Corp. · 2006 · Recalled
  5. This deviceK073519 Quickcat Extraction Catheter, Model 60090-01Kensey Nash Corp. · 2008
  6. Descendant · cites it directly · 0 of its ownK091703 HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130…Concentric Medical, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K091703HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131Concentric Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K010579Stent Support Guide CatheterMedtronic Vascular200127
−3K030201Modification to Export Aspiration CatheterMedtronic Vascular2003—
−2K040869Export CatheterMedtronic Vascular2004—
−1K060092Quickcat Extraction CatheterKensey Nash Corp.20061
0 (this device)K073519Quickcat Extraction Catheter, Model 60090-01Kensey Nash Corp.2008—
+1K091703HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131Concentric Medical, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200230
200310
200410
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K073519, 2001–2009Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K060092Quickcat Extraction Catheter
Summary page 5
…Class II Device Product Code: DXE Predicate Device: Kensey Nash Corporation's QuickCat T Extraction Catheter (K060092) Date Prepared: December 12, 2007 Description of Device: The QuickCatTM Extraction Catheter is a single use, d…
Kensey Nash Corp.20061

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091703HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131Concentric Medical, Inc.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 1, 2010Not classifiedZ-2190-2010Process controlGuidewire lumen may be occluded, preventing guidewire insertion into the catheter.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 5 of the 11 ancestors have a recall of any class.
  • Of its descendants, K091703 (Concentric Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.

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 QuickCatTM Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K073519: Quickcat Extraction Catheter, Model 60090-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073519

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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