510(k) · Cleared
ClearedXTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model # CT0006001; XTD Collection Bottle, Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xtrak Medical, Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on Mar 6, 2002 as substantially equivalent to K960970 (Possis Medical, Inc., 1996) and 1 other predicate after a 139-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Mar 6, 2002
- Review
- 139 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901627 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK901627 Arterial Embolectomy CatheterApplied Vascular Devices, Inc. · 1990 · Recalled
- 1 generation backK960970 Possis Angiojet Rapid Thrombectomy Catheter System, F105…Possis Medical, Inc. · 1996
- This deviceK013473 XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control…Xtrak Medical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK021641 XTD Thrombectomy Catheter, XX CMXtrak Medical, Inc. · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K021641XTD Thrombectomy Catheter, XX CMXtrak Medical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901627 | Arterial Embolectomy Catheter | Applied Vascular Devices, Inc. | 1990 | 1 |
| −1 | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model… | Possis Medical, Inc. | 1996 | — |
| 0 (this device) | K013473 | XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model… | Xtrak Medical, Inc. | 2002 | — |
| +1 | K021641 | XTD Thrombectomy Catheter, XX CM | Xtrak Medical, Inc. | 2002 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K960970 | Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140…Summary page 1…3) 896-6416 Fax: (603)893-7708 Contact: Gary Boseck, Ph.D. President Identification of Predicate or Legally Marketed Devices Possis AngioJet Rapid Thrombectomy System (K960970), manufactured by Possis Medical, inc., and Arrow-Trerotola Percutaneous Thrombolytic Device (K970080), manufac@ured by Arrow In… | 1996 |
| * | K970080 | Arrow-Trerotola PTD CatheterSummary page 1…Legally Marketed Devices Possis AngioJet Rapid Thrombectomy System (K960970), manufactured by Possis Medical, inc., and Arrow-Trerotola Percutaneous Thrombolytic Device (K970080), manufac@ured by Arrow International, Inc. Intended Use For breaking apart and removing thrombus from hemodialysis access graf… | 1997 |
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 |
|---|---|---|---|
| K021641 | XTD Thrombectomy Catheter, XX CM | 2002 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K021641 (Xtrak Medical, Inc., 2002) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K960970.
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?
For breaking apart and removing thrombus from hemodialysis access grafts.
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/K013473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013473: XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model # CT0006001; XTD Collection Bottle, Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013473
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026