510(k) · Cleared
Recalled · 2007Thromcat Thrombectomy Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corp. · MCW Catheter, Peripheral, Atherectomy
Cleared on Apr 25, 2006 as substantially equivalent to K021096 (Ev3 Corporation, 2004) and 1 other predicate after a 112-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 25, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K901627 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 2 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 1 generation backK021096 X-Sizer Catheter SystemEv3 Corporation · 2004 · Recalled
- This deviceK060016 Thromcat Thrombectomy Catheter SystemKensey Nash Corp. · 2006
- Descendant · cites it directly · 0 of its ownK072195 Thromcat Thrombectomy Catheter SystemKensey Nash Corp. · 2007
Most influential descendants
Showing 1 of 1 · See all- K072195Thromcat Thrombectomy Catheter SystemKensey Nash Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −2 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −1 | K021096 | X-Sizer Catheter System | Ev3 Corporation | 2004 | 2 |
| 0 (this device) | K060016 | Thromcat Thrombectomy Catheter System | Kensey Nash Corp. | 2006 | — |
| +1 | K072195 | Thromcat Thrombectomy Catheter System | Kensey Nash Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K021096 | X-Sizer Catheter SystemSummary page 1…evices: Manufacturer Device 5 10(k) # ev3 Inc. X-Sizer® Catheter System K021096 Microvena Corporation Amplatz Thrombectomy Device K982657 Substantial Equivalence: ThromCat is similar… | 2004 |
| * | K982657 | Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal…Summary page 1…5 10(k) # ev3 Inc. X-Sizer® Catheter System K021096 Microvena Corporation Amplatz Thrombectomy Device K982657 Substantial Equivalence: ThromCat is similar with regard to materials, intended use, principles of operation and technological c… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072195 | Thromcat Thrombectomy Catheter System | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2007 | Not classified | Z-1115-2007 | Other | Defective component (power supply) |
| Feb 7, 2007 | Not classified | Z-0597-2007 | Other | Face seal may wear excessively and cause particulate matter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K072195 (Kensey Nash Corp., 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021096.
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?
ThromCatTM Thrombectomy Catheter System is indicated for mechanical removal of thrombus in synthetic hemodialysis access grafts and native vessel dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060016 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060016: Thromcat Thrombectomy Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060016
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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