510(k) · Cleared
ClearedReact 68 Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · DQY Catheter, Percutaneous
Cleared on Jul 4, 2018 as substantially equivalent to K151667 (Stryker, 2015) and 1 other predicate after a 107-day review. Its family tree reaches back 6 generations to 2001. 19 later devices descend from it.
- Decided
- Jul 4, 2018
- Review
- 107 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003880 (2001). 11 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 5 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 4 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- 3 generations backK110483 Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · Recalled
- 2 generations backK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
- 1 generation backK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
- This deviceK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- Descendant · cites it directly · 14 of its ownK183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal…Stryker · 2019
- Descendant · 2 generations on · 6 of its ownK190833 AXS Vecta Aspiration CatheterStryker Neurovascular · 2019
- Descendant · 2 generations on · 5 of its ownK191237 CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK202752 AXS Vecta 46 Intermediate CatheterStryker Neurovascular · 2021
- Descendant · 3 generations on · 3 of its ownK193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker · 2019 · cites it directly14descendants
- K190833AXS Vecta Aspiration CatheterStryker Neurovascular · 2019 · 2 generations on6descendants
- K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019 · 2 generations on5descendants
- K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular · 2021 · 3 generations on3descendants
- K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −5 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −4 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| −3 | K110483 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2011 | 1 |
| −2 | K133177 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2014 | 3 |
| −1 | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access… | Stryker | 2015 | 3 |
| 0 (this device) | K180715 | React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018 | — |
| +1 | K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access… | Stryker | 2019 | — |
| +2 | K190833 | AXS Vecta Aspiration Catheter | Stryker Neurovascular | 2019 | — |
| +2 | K191237 | CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. | 2019 | — |
| +3 | K202752 | AXS Vecta 46 Intermediate Catheter | Stryker Neurovascular | 2021 | — |
| +3 | K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Codman & Shurtleff, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 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 |
|---|---|---|---|
| * | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Summary page 4…e: Percutaneous Catheter Device Classification: Class II Predicate Device(s): AXS Catalyst™ Distal Access Catheter 510(k)#: K151667 ReFlex™ Guide Catheter 510(k)#: K110055 Device Description: The React™ 68… | 2015 |
| * | K110055 | Reverse Medical Reflex Guide CatheterSummary page 4…AXS Catalyst™ Distal Access Catheter 510(k)#: K151667 ReFlex™ Guide Catheter 510(k)#: K110055 Device Description: The React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol str… | 2011 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K183463 (Stryker, 2019) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K151667.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180715 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180715: React 68 Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180715
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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