510(k) · Cleared
ClearedThromcat 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 Aug 23, 2007 as substantially equivalent to K060016 (Kensey Nash Corp., 2006) after a 16-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Aug 23, 2007
- Review
- 16 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901627 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 3 generations backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- 2 generations backK021096 X-Sizer Catheter SystemEv3 Corporation · 2004 · Recalled
- 1 generation backK060016 Thromcat Thrombectomy Catheter SystemKensey Nash Corp. · 2006 · Recalled
- This deviceK072195 Thromcat Thrombectomy Catheter SystemKensey Nash Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −3 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| −2 | K021096 | X-Sizer Catheter System | Ev3 Corporation | 2004 | 2 |
| −1 | K060016 | Thromcat Thrombectomy Catheter System | Kensey Nash Corp. | 2006 | 2 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K060016 | Thromcat Thrombectomy Catheter SystemSummary page 1…Device Product Code: MCW Predicate Device: Kensey Nash Corporation's ThromCatTM Thrombectomy Catheter System (K060016) Date Prepared: July 30, 2007 Description of Device: ThromCatTM Thrombectomy Catheter System is a single-use,… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All MCW devicesMCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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/K072195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072195: Thromcat Thrombectomy Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072195
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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