510(k) · Cleared
ClearedFetch Aspiration Catheter
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 May 11, 2007 as substantially equivalent to K042937 (Vascular Solutions, Inc., 2005) and 2 other predicates after a 93-day review. Its family tree reaches back 3 generations to 2003. 1 of the 8 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- May 11, 2007
- Review
- 93 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K032763 (2003). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK032763 Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2003 · Recalled
- 2 generations backK042937 Modification to Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2005
- 1 generation backK062172 Fetch Aspiration CatheterPossis Medical, Inc. · 2006
- This deviceK070363 Fetch Aspiration CatheterPossis Medical, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK081989 Modification to Fetch Aspiration CatheterPossis Medical, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK101354 Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · Recalled (Class I)
Class I recalls in this family
- K101354 Fetch 2 Aspiration Catheter Model 109400-0012 generations on · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032763 | Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2003 | 1 |
| −2 | K042937 | Modification to Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2005 | — |
| −1 | K062172 | Fetch Aspiration Catheter | Possis Medical, Inc. | 2006 | — |
| 0 (this device) | K070363 | Fetch Aspiration Catheter | Possis Medical, Inc. | 2007 | — |
| +1 | K081989 | Modification to Fetch Aspiration Catheter | Possis Medical, Inc. | 2008 | — |
| +2 | K101354 | Fetch 2 Aspiration Catheter Model 109400-001 | Medrad Interventional/Possis | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 1 |
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.
1 device in this family has 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 |
|---|---|---|---|
| * | K042937 | Modification to Vascular Solutions Pronto Extraction CatheterSummary page 5…Possis Medical, Inc. Possis Medical, Inc. Performance Standards: None have been developed for this device, per Section 514 Predicate Devices: Pronto Extraction Catheter (K042937), Pronto V3 Extraction Catheter (K063371) and FETCH Aspiration Catheter (K062172) Device Description The FETCH Aspiration Cath… | 2005 |
| * | K063371 | Pronto V3 Extraction Catheter, Model 5003Summary page 5…Performance Standards: None have been developed for this device, per Section 514 Predicate Devices: Pronto Extraction Catheter (K042937), Pronto V3 Extraction Catheter (K063371) and FETCH Aspiration Catheter (K062172) Device Description The FETCH Aspiration Catheter is a rapid exchange, low-profile tip,… | 2006 |
| * | K062172 | Fetch Aspiration CatheterSummary page 5…veloped for this device, per Section 514 Predicate Devices: Pronto Extraction Catheter (K042937), Pronto V3 Extraction Catheter (K063371) and FETCH Aspiration Catheter (K062172) Device Description The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014”… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081989 | Modification to Fetch Aspiration Catheter | 2008 | 1 |
Has anything in its family been recalled? (1 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.
- K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K081989 (Possis Medical, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K042937.
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 FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
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/K070363 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070363: Fetch Aspiration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070363
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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