510(k) · Cleared
ClearedAXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · DQY Catheter, Percutaneous
Cleared on Mar 13, 2019 as substantially equivalent to K151667 (Stryker, 2015) and 1 other predicate after an 89-day review. Its family tree reaches back 7 generations to 2001. 14 later devices descend from it.
- Decided
- Mar 13, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K003880 (2001). 12 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 6 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 5 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- 4 generations backK110483 Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · Recalled
- 3 generations backK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
- 2 generations backK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
- 1 generation backK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- This deviceK183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal…Stryker · 2019
- Descendant · cites it directly · 6 of its ownK190833 AXS Vecta Aspiration CatheterStryker Neurovascular · 2019
- Descendant · cites it directly · 5 of its ownK191237 CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK202752 AXS Vecta 46 Intermediate CatheterStryker Neurovascular · 2021
- Descendant · 2 generations on · 3 of its ownK193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK241244 CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K190833AXS Vecta Aspiration CatheterStryker Neurovascular · 2019 · cites it directly6descendants
- K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019 · cites it directly5descendants
- K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular · 2021 · 2 generations on3descendants
- K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020 · 2 generations on3descendants
- K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −6 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −5 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| −4 | K110483 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2011 | 1 |
| −3 | K133177 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2014 | 3 |
| −2 | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access… | Stryker | 2015 | 3 |
| −1 | K180715 | React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018 | — |
| 0 (this device) | K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access… | Stryker | 2019 | — |
| +1 | K190833 | AXS Vecta Aspiration Catheter | Stryker Neurovascular | 2019 | — |
| +1 | K191237 | CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. | 2019 | — |
| +2 | K202752 | AXS Vecta 46 Intermediate Catheter | Stryker Neurovascular | 2021 | — |
| +2 | K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Codman & Shurtleff, Inc. | 2020 | — |
| +3 | K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | Cerenovus, Inc. | 2024 | — |
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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 5…Device Additional Predicate Device Predicate AXS Catalyst Distal Access Catheter React™ 68 Catheter Device(s): (K151667) (K180715) Device Description The AXS Catalyst 7 Distal Access Catheter is a sterile, si… | 2015 |
| * | K180715 | React 68 CatheterSummary page 5…te Device Predicate AXS Catalyst Distal Access Catheter React™ 68 Catheter Device(s): (K151667) (K180715) Device Description The AXS Catalyst 7 Distal Access Catheter is a sterile, single lumen, variable stiffness catheter desig… | 2018 |
What descends from it? (14)
See all 143 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 18 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 12 ancestors have a recall of any class.
- Of its descendants, K190833 (Stryker Neurovascular, 2019) has gone furthest, with 6 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. 2019, 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 AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183463: AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183463
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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