510(k) · Cleared
Recalled · Class II · 2017AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · DQY Catheter, Percutaneous
Cleared on Nov 13, 2015 as substantially equivalent to K133177 (Concentric Medical, Inc., 2014) and 2 other predicates after a 147-day review. Its family tree reaches back 5 generations to 2001. 26 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 13, 2015
- Review
- 147 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 5 generations to K003880 (2001). 9 ancestors in all. 26 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 4 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 3 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- 2 generations backK110483 Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · Recalled
- 1 generation backK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
- This deviceK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015
- Descendant · cites it directly · 19 of its ownK180715 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 · cites it directly · 4 of its ownK234115 APRO 55 CatheterAlembic, LLC · 2024
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018 · cites it directly19descendants
- 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
- K234115APRO 55 CatheterAlembic, LLC · 2024 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −4 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −3 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| −2 | K110483 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2011 | 1 |
| −1 | K133177 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2014 | 3 |
| 0 (this device) | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access… | Stryker | 2015 | — |
| +1 | 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 | — |
| +1 | K234115 | APRO 55 Catheter | Alembic, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K133177 | Modified HD Guide CatheterSummary page 4…, 2009) Concentric HD Guide Catheter K110483 (April 4, 2011) Modified HD Guide Catheter K133177 (February 25, 2014) Modified HD Guide Catheter Device Description The AXS Catalyst™ Distal Access Catheter is a sterile,… | 2014 |
| * | K110483 | Modified HD Guide CatheterSummary page 4…): (Clearance Date) K090335 (May 6, 2009) Concentric HD Guide Catheter K110483 (April 4, 2011) Modified HD Guide Catheter K133177 (February 25, 2014) Modified HD… | 2011 |
| * | K090335 | HD Guide CatheterSummary page 4…eted Reference Device Predicate Device(s): (Clearance Date) K090335 (May 6, 2009) Concentric HD Guide Catheter K110483 (April 4, 2011) Modified… | 2009 |
What descends from it? (26)
See all 265 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2017 | Class II | Z-0275-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
| Nov 3, 2017 | Class II | Z-0276-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
| Nov 3, 2017 | Class II | Z-0277-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K180715 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2018) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K133177.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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/K151667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151667: AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151667
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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