510(k) · Cleared
Cleared7F Hydrolyser Thrombectomy Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · QEZ Aspiration Thrombectomy Catheter
Cleared on Feb 26, 1999 after a 140-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Feb 26, 1999
- Review
- 140 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK983534 7F Hydrolyser Thrombectomy CatheterCordis Corp. · 1999
- Descendant · cites it directly · 3 of its ownK041705 Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies · 2004
- Descendant · 2 generations on · 2 of its ownK052428 Resolution Endovascular SystemOmnisonics Medical Technologies · 2005
- Descendant · 3 generations on · 1 of its ownK071762 Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007
- Descendant · 4 generations on · 0 of its ownK083335 Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008
Most influential descendants
Showing 4 of 4 · See all- K041705Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies · 2004 · cites it directly3descendants
- K052428Resolution Endovascular SystemOmnisonics Medical Technologies · 2005 · 2 generations on2descendants
- K071762Omniwave Endovascular SystemOmnisonics Medical Technologies · 2007 · 3 generations on1descendant
- K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies · 2008 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983534 | 7F Hydrolyser Thrombectomy Catheter | Cordis Corp. | 1999 | — |
| +1 | K041705 | Resolution Thrombectomy System, Model EV-2 | Omnisonics Medical Technologies | 2004 | — |
| +2 | K052428 | Resolution Endovascular System | Omnisonics Medical Technologies | 2005 | — |
| +3 | K071762 | Omniwave Endovascular System | Omnisonics Medical Technologies | 2007 | — |
| +4 | K083335 | Modified Omniwave Endovascular System | Omnisonics Medical Technologies | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | — | Angiodynamics PRO™ Infusion Catheter Named without a submission number | |
| * | — | Arrow-Trerotola™ Percutaneous Thrombolytic Device Catheter Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041705 | Resolution Thrombectomy System, Model EV-2 | 2004 | 3 |
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?
- Of its descendants, K041705 (Omnisonics Medical Technologies, 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (< 5 days old) thrombus from dialysis shunts.
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/K983534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983534: 7F Hydrolyser Thrombectomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983534
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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