510(k) · Cleared
ClearedCes Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Neurovascular, Inc. · KRA Catheter, Continuous Flush
Cleared on Mar 21, 1997 after an 87-day review. The FDA summary names its predicate without a number. 83 later devices descend from it.
- Decided
- Mar 21, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 0
83 later devices descend from it, 5 citing it directly.
- This deviceK965181 Ces Infusion CatheterCordis Neurovascular, Inc. · 1997
- Descendant · cites it directly · 81 of its ownK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
- Descendant · cites it directly · 35 of its ownK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
- Descendant · 2 generations on · 34 of its ownK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- Descendant · 3 generations on · 33 of its ownK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
- Descendant · 4 generations on · 20 of its ownK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K972518Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997 · cites it directly81descendants
- K020680Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc. · 2002 · cites it directly35descendants
- K062885Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007 · 2 generations on34descendants
- K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009 · 3 generations on33descendants
- K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015 · 4 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965181 | Ces Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| +1 | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| +1 | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | Cordis Neurovascular, Inc. | 2002 | — |
| +2 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| +3 | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
| +4 | K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.5 · 9 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 |
|---|---|---|---|
| * | — | TRANSIT® Infusion Catheter Named without a submission number | |
| * | — | RapidTRANSIT® Infusion Catheter Named without a submission number | |
| * | — | Tracker Infusion Catheters Named without a submission number |
What descends from it? (83)
See all 835 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | 1997 | 81 |
| K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | 2002 | 35 |
| K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips | 2002 | 16 |
| K974222 | Ces Masstransit Infusion Catheter | 1998 | 0 |
| K971306 | FG Infusion Catheter | 1997 | 0 |
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?
- Of its descendants, K972518 (Cordis Neurovascular, Inc., 1997) has gone furthest, with 81 descendants of its own.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
CES Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic and embolic agents into the peripheral, coronary and neurovasculatures.
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/K965181 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965181: Ces Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965181
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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