510(k) · Cleared
Recalled · 2009Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit with Introducer Sheaths),PT-65
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · MCW Catheter, Peripheral, Atherectomy
Cleared on May 4, 1999 after a 53-day review. The FDA summary names its predicate without a number. 1 of the 22 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it. It has been recalled once.
- Decided
- May 4, 1999
- Review
- 53 days
- Class
- Class II
- Product code
- MCW
- Recalls
- 1
- Predicates
- 0
21 later devices descend from it, 5 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- This deviceK990829 Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models…Arrow Intl., Inc. · 1999
- Descendant · cites it directly · 13 of its ownK031610 Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical · 2003 · Recalled
- Descendant · 2 generations on · 12 of its ownK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- Descendant · cites it directly · 11 of its ownK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- Descendant · cites it directly · 11 of its ownK011056 Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc. · 2001 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K011056 Arrow-Trerotola Percutaneous Thrombolytic Device…cites it directly · 2001
Most influential descendants
Showing 5 of 21 · See all- K031610Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical · 2003 · cites it directly13descendants
- K033793Cleaner II Rotational Thrombectomy SystemRex Medical · 2003 · 2 generations on12descendants
- K040252Cleaner Rotational Thrombectomy System KitRex Medical · 2004 · cites it directly11descendants
- K011056Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc. · 2001 · cites it directly11descendants
- K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990829 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509… | Arrow Intl., Inc. | 1999 | — |
| +1 | K031610 | Rex Medical Cleaner Rotational Thrombectomy System | Rex Medical | 2003 | 1 |
| +2 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| +1 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| +1 | K011056 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD | Arrow Intl., Inc. | 2001 | Class I |
| +2 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | Arrow-Trerotola™ Percutaneous Thrombolytic Device or “PTD” Named without a submission number |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031610 | Rex Medical Cleaner Rotational Thrombectomy System | 2003 | 13 |
| K040252 | Cleaner Rotational Thrombectomy System Kit | 2004 | 11 |
| K011056 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD Class I | 2001 | 11 |
| K041705 | Resolution Thrombectomy System, Model EV-2 | 2004 | 3 |
| K030504 | Akonya Eliminator Mechanical Thrombectomy Device, Model EL 10060060 | 2003 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2009 | Not classified | Z-1501-2009 | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K011056Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 111 Class I recalls
What does this lineage say?
- Of its descendants, K031610 (Rex Medical, 2003) has gone furthest, with 13 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 Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit (PT-03000-R), permits mechanical declotting of synthetic dialysis 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/K990829 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990829: Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit with Introducer Sheaths),PT-65.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990829
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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