510(k) · Cleared
Recalled · Class II · 2009Diver C.E. Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invatec Innovative Technologies, S.R.L. · QEZ Aspiration Thrombectomy Catheter
Cleared on Aug 8, 2005 as substantially equivalent to K050276 (Invatec Innovative Technologies, S.R.L., 2005) and 4 other predicates after a 24-day review. Its family tree reaches back 2 generations to 2003. 13 later devices descend from it. It has been recalled once.
- Decided
- Aug 8, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 2 generations to K032763 (2003). 7 ancestors in all, the oldest K883718 (1989). 13 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK032763 Vascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. · 2003 · Recalled
- 1 generation backK050276 Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · Recalled
- This deviceK051917 Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005
- Descendant · cites it directly · 12 of its ownK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 11 of its ownK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- Descendant · 3 generations on · 10 of its ownK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- Descendant · 4 generations on · 4 of its ownK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010 · Recalled
- Descendant · 5 generations on · 3 of its ownK161506 Penumbra Aspiration SystemPenumbra, Inc. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K071727QXT Extraction CatheterVascular Solutions, Inc. · 2007 · cites it directly12descendants
- K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007 · 2 generations on11descendants
- K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc. · 2009 · 3 generations on10descendants
- K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc. · 2010 · 4 generations on4descendants
- K161506Penumbra Aspiration SystemPenumbra, Inc. · 2016 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032763 | Vascular Solutions Pronto Extraction Catheter | Vascular Solutions, Inc. | 2003 | 1 |
| −1 | K050276 | Diver C.E. Catheter | Invatec Innovative Technologies, S.R.L. | 2005 | 1 |
| 0 (this device) | K051917 | Diver C.E. Catheter | Invatec Innovative Technologies, S.R.L. | 2005 | — |
| +1 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| +2 | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | Vascular Solutions, Inc. | 2007 | — |
| +3 | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model… | Vascular Solutions, Inc. | 2009 | — |
| +4 | K103405 | Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… | Vascular Solutions, Inc. | 2010 | 1 |
| +5 | K161506 | Penumbra Aspiration System | Penumbra, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K050276 | Diver C.E. CatheterSummary page 5…heter Common Name/Usual Name: Catheter, Embolectomy Classification Name: Catheter, Embolectomy Class: Class I, 21 CFR 870.5150 Predicate Devices: DIVER™ C.E. Catheter — K050276 Vascular Solutions Inc. PRONTO™ Extraction Catheter — K032763 VacLok™ Syringe — K994253 Hi-Flex™ High Pressure Tubing — K883718 S… | 2005 |
| * | K032763 | Vascular Solutions Pronto Extraction CatheterSummary page 5…tion Name: Catheter, Embolectomy Class: Class I, 21 CFR 870.5150 Predicate Devices: DIVER™ C.E. Catheter — K050276 Vascular Solutions Inc. PRONTO™ Extraction Catheter — K032763 VacLok™ Syringe — K994253 Hi-Flex™ High Pressure Tubing — K883718 Stopcock (One-port Manifold) — K934123 Page 1 of 2 === Page 6… | 2003 |
| * | K994253 | Vaclok SyringeSummary page 5…ectomy Class: Class I, 21 CFR 870.5150 Predicate Devices: DIVER™ C.E. Catheter — K050276 Vascular Solutions Inc. PRONTO™ Extraction Catheter — K032763 VacLok™ Syringe — K994253 Hi-Flex™ High Pressure Tubing — K883718 Stopcock (One-port Manifold) — K934123 Page 1 of 2 Losia1? ?,20‘62. Dev… | 2000 |
| * | K883718 | Merit HI-Flex (TM)Summary page 5…Predicate Devices: DIVER™ C.E. Catheter — K050276 Vascular Solutions Inc. PRONTO™ Extraction Catheter — K032763 VacLok™ Syringe — K994253 Hi-Flex™ High Pressure Tubing — K883718 Stopcock (One-port Manifold) — K934123 Page 1 of 2 Losia1? ?,20‘62. Device Description: The DIVER C.E. Catheter… | 1989 |
| * | K934123 | Stopcock (One-Port Manifold)Summary page 5…— K050276 Vascular Solutions Inc. PRONTO™ Extraction Catheter — K032763 VacLok™ Syringe — K994253 Hi-Flex™ High Pressure Tubing — K883718 Stopcock (One-port Manifold) — K934123 Page 1 of 2 Losia1? ?,20‘62. Device Description: The DIVER C.E. Catheter is an aspiration catheter indicated fo… | 1993 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071727 | QXT Extraction Catheter | 2007 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2009 | Class II | Z-1517-2013 | Labeling False and Misleading | Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K071727 (Vascular Solutions, Inc., 2007) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K050276.
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 DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and
thrombi from vessels in the arterial system.
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/K051917 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051917: Diver C.E. Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051917
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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