510(k) · Cleared
ClearedExcelsior 1018 Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific, Target · KRA Catheter, Continuous Flush
Cleared on Aug 3, 2000 as substantially equivalent to K960806 (Target Therapeutics, 1996) after a 238-day review. Its family tree reaches back 1 generation to 1996. 120 later devices descend from it.
- Decided
- Aug 3, 2000
- Review
- 238 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960806 (1996). 120 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK960806 Turbo TrackerTarget Therapeutics · 1996
- This deviceK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- Descendant · cites it directly · 81 of its ownK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- Descendant · 2 generations on · 39 of its ownK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- Descendant · cites it directly · 35 of its ownK050599 Tracker Excel -14 Pre-Shaped MicrocatheterBoston Scientific Corp · 2005
- Descendant · 2 generations on · 34 of its ownK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- Descendant · 2 generations on · 33 of its ownK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · cites it directly81descendants
- K083343Headway 17 MicrocatheterMicroVention, Inc. · 2008 · 2 generations on39descendants
- K050599Tracker Excel -14 Pre-Shaped MicrocatheterBoston Scientific Corp · 2005 · cites it directly35descendants
- K062885Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007 · 2 generations on34descendants
- K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| 0 (this device) | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| +1 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| +2 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| +1 | K050599 | Tracker Excel -14 Pre-Shaped Microcatheter | Boston Scientific Corp | 2005 | — |
| +2 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| +2 | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 8 | 0 |
| 2020 | 10 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 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 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 14.4 · 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? (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 |
|---|---|---|---|
| * | K960806 | Turbo TrackerSummary page 1…ast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. Predicate Device: : TurboTracker®-18 Infusion Catheter K960806, cleared May 2, 1996 Testing in Support of Substantial Equivalence Determination The Excelsior 1018 Microcatheter has different… | 1996 |
| † | K962503 | Guglielmi Detachable Coil | 1996 |
What descends from it? (120)
See all 1204 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | 2001 | 81 |
| K050599 | Tracker Excel -14 Pre-Shaped Microcatheter | 2005 | 35 |
| K042568 | Excelsior 1018 and SL-10 Microcatheters | 2004 | 25 |
| K123452 | Tracker-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal Shaft, Tracker-17… | 2013 | 1 |
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?
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?
The Excelsior 1018 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.
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/K994155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994155: Excelsior 1018 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994155
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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