510(k) · Cleared
Recalled · Class II · 2024Modified HD Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concentric Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 25, 2014 as substantially equivalent to K090335 (Concentric Medical, Inc., 2009) and 2 other predicates after a 131-day review. Its family tree reaches back 4 generations to 2001. 28 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 25, 2014
- Review
- 131 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 4 generations to K003880 (2001). 8 ancestors in all. 28 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 3 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 2 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- 1 generation backK110483 Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · Recalled
- This deviceK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014
- Descendant · cites it directly · 26 of its ownK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
- Descendant · 2 generations on · 19 of its ownK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- Descendant · 2 generations on · 14 of its ownK183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal…Stryker · 2019
- Descendant · 3 generations on · 6 of its ownK190833 AXS Vecta Aspiration CatheterStryker Neurovascular · 2019
- Descendant · 3 generations on · 5 of its ownK191237 CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker · 2015 · cites it directly26descendants
- K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018 · 2 generations on19descendants
- K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker · 2019 · 2 generations on14descendants
- K190833AXS Vecta Aspiration CatheterStryker Neurovascular · 2019 · 3 generations on6descendants
- K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −3 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −2 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| −1 | K110483 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2011 | 1 |
| 0 (this device) | K133177 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2014 | — |
| +1 | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access… | Stryker | 2015 | 3 |
| +2 | K180715 | React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018 | — |
| +2 | K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access… | Stryker | 2019 | — |
| +3 | K190833 | AXS Vecta Aspiration Catheter | Stryker Neurovascular | 2019 | — |
| +3 | K191237 | CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. | 2019 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 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 |
|---|---|---|---|
| * | K090335 | HD Guide CatheterSummary page 1…roduct Code: DQY and OQO Legally Marketed Reference Device Predicate Devices: (Clearance Date) K090335 (May 6, 2009) Concentric HD Guide Catheter KI 10483 (April 4, 2011) Modified H… | 2009 |
| * | K110483 | Modified HD Guide CatheterSummary page 2…hnological Characteristics and Product Feature Comparison: The subject device has the same technological characteristics as the predicate devices (K090335 and K1 10483). The device design, materials, fundamental scientific technology, materials and processes for packaging and sterilization h… | 2011 |
| * | K112404 | Concentric Balloon Guide CatheterSummary page 2…aging and sterilization have not been changed from the previous predicate devices (K090335 and KI 10483). The subject device differs from the predicate device, K1 12404 primarily in that it does not include a balloon at the distal tip or a second lumen. A tabular comparison of the speci… | 2012 |
What descends from it? (28)
See all 282 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 |
|---|---|---|---|---|
| Apr 23, 2024 | Class II | Z-1908-2024 | Process design | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin… |
| Apr 3, 2024 | Class II | Z-1740-2024 | Release of Material/Component prior to receiving test results | Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results. |
| Aug 19, 2015 | Class II | Z-0116-2016 | Employee error | One Distal Access Catheter intended for distribution in Korea, was found at a US location. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K151667 (Stryker, 2015) has gone furthest, with 26 descendants of its own.
- 3 other devices also cite its predicate K090335.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Concentric HID Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval 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/K133177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133177: Modified HD Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133177
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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