510(k) · Cleared
ClearedThrombolytic Brush Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Aug 8, 1997 as substantially equivalent to K954205 (Microvena Corp., 1996) after a 312-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Aug 8, 1997
- Review
- 312 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954205 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954205 The Amplatz Thrombectomy DeviceMicrovena Corp. · 1996
- This deviceK963925 Thrombolytic Brush CatheterMicro Therapeutics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK012641 Fas Endoluminal BrushFas Medical, Ltd. · 2001
- Descendant · 2 generations on · 0 of its ownK072518 CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK973669 Thrombolytic Brush Catheter, Over the Wire (Otw)Micro Therapeutics, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K012641Fas Endoluminal BrushFas Medical, Ltd. · 2001 · cites it directly1descendant
- K072518CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007 · 2 generations on0descendants
- K973669Thrombolytic Brush Catheter, Over the Wire (Otw)Micro Therapeutics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954205 | The Amplatz Thrombectomy Device | Microvena Corp. | 1996 | — |
| 0 (this device) | K963925 | Thrombolytic Brush Catheter | Micro Therapeutics, Inc. | 1997 | — |
| +1 | K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2001 | — |
| +2 | K072518 | CRS Fibrin Analysis Catheter Testing System (Facts) | Crs Medical Diagnostics, Inc. | 2007 | — |
| +1 | K973669 | Thrombolytic Brush Catheter, Over the Wire (Otw) | Micro Therapeutics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 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 MCW? 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 MCW device
- #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 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 |
|---|---|---|---|
| * | K954205 | The Amplatz Thrombectomy DeviceSummary page 1…ediTech Mewissen Infusion Catheter. This product is equivalent in intended use as well as composition and function to the legally marketed Amplatz Thrombectomy Device, (K954205) manufactured by Microvena, Corporation. Jul-22-97 13:43 MTI/MICRO THERAPEUTICS 1 714 361 0210 FP.11 Summary of… | 1996 |
| * | — | Fogarty® Graft Thrombectomy Catheter (Baxter Corp.) Named without a submission number | |
| * | — | Mewissen Infusion Catheter (MediTech) Named without a submission number |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K012641 (Fas Medical, Ltd., 2001) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MCW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCW
46in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MCW
2in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MCW
677in 2025
MAUDE reports naming product code MCW, 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 | 43 | 2 | 50 |
| 2008 | 6 | 33 | 1 | 115 |
| 2009 | 8 | 27 | 3 | 105 |
| 2010 | 6 | 30 | 1 | 167 |
| 2011 | 6 | 39 | 0 | 204 |
| 2012 | 5 | 29 | 0 | 194 |
| 2013 | 5 | 30 | 0 | 134 |
| 2014 | 7 | 117 | 0 | 210 |
| 2015 | 6 | 30 | 0 | 377 |
| 2016 | 5 | 60 | 2 | 409 |
| 2017 | 7 | 91 | 2 | 415 |
| 2018 | 8 | 103 | 0 | 537 |
| 2019 | 3 | 112 | 0 | 618 |
| 2020 | 2 | — | 0 | 631 |
| 2021 | 6 | 119 | 2 (2) | 734 |
| 2022 | 6 | 69 | 2 (2) | 566 |
| 2023 | 4 | 104 | 1 | 574 |
| 2024 | 3 | 41 | 2 | 677 |
| 2025 | 3 | 46 | 0 | 677 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Micro Therapeutics Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus (i.e., less than two weeks old) located in artificial arteriovenous (A-V) grafts. The Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. Clinical studies demonstrate effective dissolution of thrombus in A-V grafts when this product is used in conjunction with urokinase. The Thrombolytic Brush Catheter is not intended for use in native vessels. The device should not be used on patients with a history of significant pulmonary disease or pulmonary hypertension.
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/K963925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963925: Thrombolytic Brush Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963925
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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