510(k) · Cleared
ClearedAnchor Dual Lumen Guidewire Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aqure Medical, Inc. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Aug 6, 2020 as substantially equivalent to K140080 (Codman & Shurtleff, Inc., 2014) and 1 other predicate after a 106-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Aug 6, 2020
- Review
- 106 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010954 (2001). 17 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet.
- Root · 7 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 6 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 5 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 4 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 3 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- 2 generations backK111380 Neuron Max SystemPenumbra, Inc. · 2011
- 1 generation backK151396 MIVI Mi-AXUS Guide CatheterMivi Neuroscience, Inc. · 2015 · Recalled
- This deviceK201076 Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −6 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −5 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −4 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −3 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| −2 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
| −1 | K151396 | MIVI Mi-AXUS Guide Catheter | Mivi Neuroscience, Inc. | 2015 | 2 |
| 0 (this device) | K201076 | Anchor Dual Lumen Guidewire Catheter | Aqure Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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 QJP? 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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 6 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 |
|---|---|---|---|
| * | K140080 | Envoy Distal Access (DA) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB…Summary page 5…Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter 1 510K Number: K140080 PREDICATE DEVICE: Proprietary Name: MIVI Mi-Axus™ Guide Catheter Common/Usual Name: Catheter, Percu… | 2014 |
| * | K151396 | MIVI Mi-AXUS Guide CatheterSummary page 5…I Mi-Axus™ Guide Catheter Common/Usual Name: Catheter, Percutaneous Classification Name: Percutaneous Catheter 510K Number: K151396 DEVICE DESCRIPTION: The Anchor Dual Lumen Guidewire Catheter, model AQ8001, is a single use, sterile (EO), 8F, 110 cm (working… | 2015 |
| † | K141981 | Asahi Fubuki 043 / Asahi Fubuki | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 17 ancestors have a recall of any class.
- 2 other devices also cite its predicate K140080.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
What is it indicated for?
The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.
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/K201076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201076: Anchor Dual Lumen Guidewire Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201076
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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