510(k) · Cleared
ClearedFlexor Evac Aspiration Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Mar 4, 2008 as substantially equivalent to K061958 (Medtronic Vascular, 2006) and 1 other predicate after a 69-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 4, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010579 (2001). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 3 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 2 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 1 generation backK061958 Medtronic Export XT CatheterMedtronic Vascular · 2006 · Recalled
- This deviceK073627 Flexor Evac Aspiration CatheterCook, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −3 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −2 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −1 | K061958 | Medtronic Export XT Catheter | Medtronic Vascular | 2006 | 1 |
| 0 (this device) | K073627 | Flexor Evac Aspiration Catheter | Cook, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K061958 | Medtronic Export XT CatheterSummary page 5…ics to predicate devices reviewed as devices for removal of fresh, soft thrombi/emboli from the peripheral arterial system. These devices include the Export XT Catheter (K061958) and the Pronto V3 Extraction Catheter (K063371). Device Description: The Flexor Evac Aspiration Catheter is hydrophilically co… | 2006 |
| * | K063371 | Pronto V3 Extraction Catheter, Model 5003Summary page 5…removal of fresh, soft thrombi/emboli from the peripheral arterial system. These devices include the Export XT Catheter (K061958) and the Pronto V3 Extraction Catheter (K063371). Device Description: The Flexor Evac Aspiration Catheter is hydrophilically coated, Flexor(® material with a radiopaque band.… | 2006 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 6 other devices also cite its predicate K061958.
How does its category compare?
All QEZ devicesQEZ 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
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?
Intended for removal of fresh, soft thrombi/emboli from the peripheral arterial system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073627: Flexor Evac Aspiration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073627
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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