510(k) · Cleared
ClearedCERENOVUS Large Bore Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · DQY Catheter, Percutaneous
Cleared on Nov 8, 2019 as substantially equivalent to K183463 (Stryker, 2019) after a 184-day review. Its family tree reaches back 8 generations to 2001. 5 later devices descend from it.
- Decided
- Nov 8, 2019
- Review
- 184 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003880 (2001). 13 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK003880 Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021…Concentric Medical, Inc. · 2001
- 7 generations backK080583 Modified HD Guide CatheterConcentric Medical, Inc. · 2008
- 6 generations backK090335 HD Guide CatheterConcentric Medical, Inc. · 2009
- 5 generations backK110483 Modified HD Guide CatheterConcentric Medical, Inc. · 2011 · Recalled
- 4 generations backK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
- 3 generations backK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
- 2 generations backK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
- 1 generation backK183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal…Stryker · 2019
- This deviceK191237 CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK221930 CEREGLIDE 71 Intermediate CatheterCerenovus, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK221934 CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK251828 CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233988 Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020 · cites it directly3descendants
- K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc. · 2023 · cites it directly1descendant
- K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2023 · 2 generations on1descendant
- K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2025 · 2 generations on0descendants
- K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022… | Concentric Medical, Inc. | 2001 | — |
| −7 | K080583 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2008 | — |
| −6 | K090335 | HD Guide Catheter | Concentric Medical, Inc. | 2009 | — |
| −5 | K110483 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2011 | 1 |
| −4 | K133177 | Modified HD Guide Catheter | Concentric Medical, Inc. | 2014 | 3 |
| −3 | 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 | — |
| −1 | K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access… | Stryker | 2019 | — |
| 0 (this device) | K191237 | CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. | 2019 | — |
| +1 | K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Codman & Shurtleff, Inc. | 2020 | — |
| +1 | K221930 | CEREGLIDE 71 Intermediate Catheter | Cerenovus, Inc. | 2023 | — |
| +2 | K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2023 | — |
| +2 | K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2025 | — |
| +2 | K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Summary page 5…AXS Catalyst Distal Access Catheter (K191237) (K183463) Product Code DQY Same Regul… | 2019 |
What descends from it? (5)
2 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 4 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 13 ancestors have a recall of any class.
- Of its descendants, K193380 (Codman & Shurtleff, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K183463.
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 CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CERENOVUS Large Bore Catheter is also indicated for use 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/K191237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191237: CERENOVUS Large Bore Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191237
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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