510(k) · Cleared
ClearedVentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Control Medical Technology, Inc. / Dba Ventiv Scientific · QEZ Aspiration Thrombectomy Catheter
Cleared on Mar 24, 2025 as substantially equivalent to K200871 (Control Medical Technology, 2020) after an 81-day review. Its family tree reaches back 10 generations to 1990. 3 of the 75 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 24, 2025
- Review
- 81 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K904788 (1990). 74 ancestors in all, the oldest K832023 (1983). No later device cites it as a predicate yet. 3 of the 75 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 6 generations between
- 3 generations backK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- 2 generations backK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- 1 generation backK200871 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire…Control Medical Technology · 2020
- This deviceK250013 VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific · 2025
Show all 10 generations
- Root · 10 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 9 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 8 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 7 generations backK031485 Rinspiration SystemKerberos Proximal Solutions · 2003
- 6 generations backK041291 Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004
- 5 generations backK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- 4 generations backK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
- 3 generations backK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- 2 generations backK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- 1 generation backK200871 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire…Control Medical Technology · 2020
- This deviceK250013 VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −9 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −8 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −7 | K031485 | Rinspiration System | Kerberos Proximal Solutions | 2003 | — |
| −6 | K041291 | Rinspiration System | Kerberos Proximal Solutions, Inc. | 2004 | — |
| −5 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| −4 | K062275 | Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 | Kerberos Proximal Solutions, Inc. | 2006 | — |
| −3 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| −2 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| −1 | K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical… | Control Medical Technology | 2020 | — |
| 0 (this device) | K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S… | Control Medical Technology, Inc. / Dba Ventiv Scientific | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 1 |
| 1998 | 8 | 1 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 1 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 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.
3 devices in this family have 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? (1)
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 |
|---|---|---|---|
| * | K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorSummary page 5…Embolectomy Catheter Classification Name: 21 CFR §870.5150, Product Code QEZ Device Class: Class II Primary Predicate 510(k) No.: K200871 Device: Model: Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspi… | 2020 |
| † | K101497 | Delivery Sheath, Model Adelante Breezeway | 2010 |
| † | K122958 | Delivery Sheath, Model Adelante Breezeway | 2012 |
| † | K181463 | DuraSheath Introducer Sheath System | 2018 |
| † | K210627 | Breezeway II | 2021 |
| † | K221914 | Catapult Guide Sheath | 2022 |
| † | K240957 | Catapult Guide Sheath | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 8 companies; a new generation was cleared every 3.4 years on median.
- 14 of the 74 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. .
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250013: VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250013
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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