510(k) · Cleared
ClearedQXT Extraction Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · QEZ Aspiration Thrombectomy Catheter
Cleared on Sep 28, 2007 as substantially equivalent to K052232 (Vascular Solutions, Inc., 2005) and 4 other predicates after a 95-day review. Its family tree reaches back 3 generations to 2001. 12 later devices descend from it.
- Decided
- Sep 28, 2007
- Review
- 95 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K010579 (2001). 16 ancestors in all, the oldest K883718 (1989). 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 2 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 1 generation backK040869 Export CatheterMedtronic Vascular · 2004
- This deviceK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 10 of its ownK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- Descendant · 3 generations on · 4 of its ownK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 3 of its ownK161506 Penumbra Aspiration SystemPenumbra, Inc. · 2016
- Descendant · 5 generations on · 2 of its ownK163618 INDIGO Aspiration SystemPenumbra, Inc. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007 · cites it directly11descendants
- K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc. · 2009 · 2 generations on10descendants
- K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc. · 2010 · 3 generations on4descendants
- K161506Penumbra Aspiration SystemPenumbra, Inc. · 2016 · 4 generations on3descendants
- K163618INDIGO Aspiration SystemPenumbra, Inc. · 2017 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −2 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −1 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| 0 (this device) | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| +1 | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | Vascular Solutions, Inc. | 2007 | — |
| +2 | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model… | Vascular Solutions, Inc. | 2009 | — |
| +3 | K103405 | Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… | Vascular Solutions, Inc. | 2010 | 1 |
| +4 | K161506 | Penumbra Aspiration System | Penumbra, Inc. | 2016 | — |
| +5 | K163618 | INDIGO Aspiration System | Penumbra, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052232 | Vascular Solutions Pronto V3 Extraction CatheterSummary page 5…Class: II Classification Name: Embolectomy catheter (21CPR 870.5150, Product Code DXE) Predicate Device(s) ProntoTM V3 Extraction Catheter (K052232 and K06337 1) manufactured by Vascular Solutions, Inc. Diver Tm C.E. Catheter (K051917 and K050276) submitted by ev3. Exp… | 2005 |
| * | K063371 | Pronto V3 Extraction Catheter, Model 5003Summary page 5…Classification Name: Embolectomy catheter (21CPR 870.5150, Product Code DXE) Predicate Device(s) ProntoTM V3 Extraction Catheter (K052232 and K06337 1) manufactured by Vascular Solutions, Inc. Diver Tm C.E. Catheter (K051917 and K050276) submitted by ev3. Export® XT Extra… | 2006 |
| * | K051917 | Diver C.E. CatheterSummary page 5…0, Product Code DXE) Predicate Device(s) ProntoTM V3 Extraction Catheter (K052232 and K06337 1) manufactured by Vascular Solutions, Inc. Diver Tm C.E. Catheter (K051917 and K050276) submitted by ev3. Export® XT Extraction Catheter (K040869 and K061059) manufactured by Medtronic Vascular, Inc… | 2005 |
| * | K050276 | Diver C.E. CatheterSummary page 5…ode DXE) Predicate Device(s) ProntoTM V3 Extraction Catheter (K052232 and K06337 1) manufactured by Vascular Solutions, Inc. Diver Tm C.E. Catheter (K051917 and K050276) submitted by ev3. Export® XT Extraction Catheter (K040869 and K061059) manufactured by Medtronic Vascular, Inc. Device D… | 2005 |
| * | K040869 | Export CatheterSummary page 5…er (K052232 and K06337 1) manufactured by Vascular Solutions, Inc. Diver Tm C.E. Catheter (K051917 and K050276) submitted by ev3. Export® XT Extraction Catheter (K040869 and K061059) manufactured by Medtronic Vascular, Inc. Device Description The QXT catheter is designed to aspirate or extr… | 2004 |
| Kept off the family tree | K061059 | FDA’s K061059 is Modified Merci Retriever, Model 90092 Our reading of the summary gave K061059, FDA’s number for Modified Merci Retriever, Model 90092 (Concentric Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Export XT Extraction Catheter”. Kept off the family tree. Summary page 5…and K06337 1) manufactured by Vascular Solutions, Inc. Diver Tm C.E. Catheter (K051917 and K050276) submitted by ev3. Export® XT Extraction Catheter (K040869 and K061059) manufactured by Medtronic Vascular, Inc. Device Description The QXT catheter is designed to aspirate or extract soft thr… | 2006 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | 2007 | 11 |
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 6 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K072810 (Vascular Solutions, Inc., 2007) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K052232.
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 QXT catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071727: QXT Extraction Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071727
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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