510(k) · Cleared
ClearedThe Amplatz Thrombectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microvena Corp. · MCW Catheter, Peripheral, Atherectomy
Cleared on Aug 13, 1996 after a 341-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Aug 13, 1996
- Review
- 341 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK954205 The Amplatz Thrombectomy DeviceMicrovena Corp. · 1996
- Descendant · cites it directly · 3 of its ownK963925 Thrombolytic Brush CatheterMicro Therapeutics, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK012641 Fas Endoluminal BrushFas Medical, Ltd. · 2001
- Descendant · 3 generations on · 0 of its ownK072518 CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK973669 Thrombolytic Brush Catheter, Over the Wire (Otw)Micro Therapeutics, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K963925Thrombolytic Brush CatheterMicro Therapeutics, Inc. · 1997 · cites it directly3descendants
- K012641Fas Endoluminal BrushFas Medical, Ltd. · 2001 · 2 generations on1descendant
- K072518CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007 · 3 generations on0descendants
- K973669Thrombolytic Brush Catheter, Over the Wire (Otw)Micro Therapeutics, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954205 | The Amplatz Thrombectomy Device | Microvena Corp. | 1996 | — |
| +1 | K963925 | Thrombolytic Brush Catheter | Micro Therapeutics, Inc. | 1997 | — |
| +2 | K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2001 | — |
| +3 | K072518 | CRS Fibrin Analysis Catheter Testing System (Facts) | Crs Medical Diagnostics, Inc. | 2007 | — |
| +2 | K973669 | Thrombolytic Brush Catheter, Over the Wire (Otw) | Micro Therapeutics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Fogarty Arterial Embolectomy Catheters (pre-amendment) Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963925 | Thrombolytic Brush Catheter | 1997 | 3 |
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, K963925 (Micro Therapeutics, Inc., 1997) has gone furthest, with 3 descendants 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 Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.
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/K954205 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954205: The Amplatz Thrombectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954205
Report an extraction error
Are you the manufacturer?
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