510(k) · Cleared
ClearedPronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support 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 Mar 30, 2009 as substantially equivalent to K063371 (Vascular Solutions, Inc., 2006) and 2 other predicates after a 101-day review. Its family tree reaches back 5 generations to 2001. 1 of the 31 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Mar 30, 2009
- Review
- 101 days
- Class
- Class II
- Product code
- QEZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K010579 (2001). 20 ancestors in all, the oldest K883718 (1989). 10 later devices descend from it, 4 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK010579 Stent Support Guide CatheterMedtronic Vascular · 2001 · Recalled
- 4 generations backK030201 Modification to Export Aspiration CatheterMedtronic Vascular · 2003
- 3 generations backK040869 Export CatheterMedtronic Vascular · 2004
- 2 generations backK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- 1 generation backK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- This deviceK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK161506 Penumbra Aspiration SystemPenumbra, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK163618 INDIGO Aspiration SystemPenumbra, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK162467 Twin-Pass TorqueVascular Solutions, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK200324 NHancer RxImds Operations B.V. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…direct predicate · 2006
Most influential descendants
Showing 5 of 10 · See all- K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc. · 2010 · cites it directly4descendants
- K161506Penumbra Aspiration SystemPenumbra, Inc. · 2016 · 2 generations on3descendants
- K163618INDIGO Aspiration SystemPenumbra, Inc. · 2017 · 3 generations on2descendants
- K162467Twin-Pass TorqueVascular Solutions, Inc. · 2017 · cites it directly2descendants
- K200324NHancer RxImds Operations B.V. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010579 | Stent Support Guide Catheter | Medtronic Vascular | 2001 | 27 |
| −4 | K030201 | Modification to Export Aspiration Catheter | Medtronic Vascular | 2003 | — |
| −3 | K040869 | Export Catheter | Medtronic Vascular | 2004 | — |
| −2 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| −1 | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | Vascular Solutions, Inc. | 2007 | — |
| 0 (this device) | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model… | Vascular Solutions, Inc. | 2009 | — |
| +1 | K103405 | Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… | Vascular Solutions, Inc. | 2010 | 1 |
| +2 | K161506 | Penumbra Aspiration System | Penumbra, Inc. | 2016 | — |
| +3 | K163618 | INDIGO Aspiration System | Penumbra, Inc. | 2017 | — |
| +1 | K162467 | Twin-Pass Torque | Vascular Solutions, Inc. | 2017 | — |
| +2 | K200324 | NHancer Rx | Imds Operations B.V. | 2020 | — |
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 | 5 | 0 |
| 2006 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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.
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 |
|---|---|---|---|
| * | K063371 | Pronto V3 Extraction Catheter, Model 5003Summary page 7…Name Trade Name Predicate Device (Classification) Embolectomy Pronto® V3 extraction catheter K063371 Pronto V3 extraction catheter catheter (21hCFr870.5150 Pronto® LP extraction catheter K072810 Pronto… | 2006 |
| * | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010Summary page 7…Pronto® V3 extraction catheter K063371 Pronto V3 extraction catheter catheter (21hCFr870.5150 Pronto® LP extraction catheter K072810 Pronto LP extraction catheter (21 CFR 870.5150) Perctatheter Skyway® RX support catheter K060327 Sky… | 2007 |
| * | K060327 | Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterSummary page 7…150 Pronto® LP extraction catheter K072810 Pronto LP extraction catheter (21 CFR 870.5150) Perctatheter Skyway® RX support catheter K060327 Skyway RX support catheter catheter Skyway ® OTW support catheter K060327 Skyway OTW support catheter… | 2006 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K103405 (Vascular Solutions, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K063371.
How does its category compare?
All QEZ devicesQEZ Aspiration Thrombectomy Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKYWAY OTW also may be used to subselectively infuse/deliver therapeutic agents. The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires…
Read the full statement (130 words)
The SKYWAY support catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The SKYWAY OTW also may be used to subselectively infuse/deliver therapeutic agents.
The TWIN-PASS dual access catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
The PRONTO extraction 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/K083784 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083784
Report an extraction error
Are you the manufacturer?
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