510(k) · Cleared
Recalled · Class I · 2022Arrow-Trerotola Percutaneous Thrombolytic Device or PTD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · QEW Peripheral Mechanical Thrombectomy With Aspiration
Cleared on Oct 24, 2001 as substantially equivalent to K990829 (Arrow Intl., Inc., 1999) after a 201-day review. Its family tree reaches back 1 generation to 1999. 1 of the 13 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it. It has been recalled 13 times, including 11 Class I recalls.
- Decided
- Oct 24, 2001
- Review
- 201 days
- Class
- Class II
- Product code
- QEW
- Recalls
- 13 (11 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990829 (1999). 11 later devices descend from it, 2 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK990829 Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models…Arrow Intl., Inc. · 1999 · Recalled
- This deviceK011056 Arrow-Trerotola Percutaneous Thrombolytic Device or PTDArrow Intl., Inc. · 2001
- Descendant · cites it directly · 9 of its ownK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
- Descendant · 2 generations on · 8 of its ownK120346 Cleaner Rotational Thrombectomy SystemRex Medical · 2012
- Descendant · 2 generations on · 7 of its ownK141617 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014
- Descendant · 3 generations on · 5 of its ownK211798 Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK223891 Cobra Catheter SystemEndovascular Engineering · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010 · cites it directly9descendants
- K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012 · 2 generations on8descendants
- K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2014 · 2 generations on7descendants
- K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc. · 2022 · 3 generations on5descendants
- K223891Cobra Catheter SystemEndovascular Engineering · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990829 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509… | Arrow Intl., Inc. | 1999 | 1 |
| 0 (this device) | K011056 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD | Arrow Intl., Inc. | 2001 | — |
| +1 | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) | Rex Medical | 2010 | — |
| +2 | K120346 | Cleaner Rotational Thrombectomy System | Rex Medical | 2012 | — |
| +2 | K141617 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2014 | — |
| +3 | K211798 | Cleaner Plus Thrombectomy System | Argon Medical Devices, Inc. | 2022 | — |
| +4 | K223891 | Cobra Catheter System | Endovascular Engineering | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 QEW device
- #1 K213402 Triever24, Triever20score 28.6 · 5 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 |
|---|---|---|---|
| * | K990829 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit…Summary page 5…heter and PTD™ Device classification Class Il at 21 CFR 870.5150, Embolectomy catheter name: Legally marketed devices to which the device is substantially equivalent: K990829 Arrow-Trerotola™ Percutaneous Thrombolytic Device Description of device The Arrow-Trerotola™ PTD™ Catheter Assembly consists o… | 1999 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2022 | Class I | Z-0624-2022 | Process change control | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | Class I | Z-0625-2022 | Process change control | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | Class I | Z-0629-2022 | Process change control | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | Class I | Z-0623-2022 | Process change control | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | Class I | Z-0626-2022 | Process change control | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | Class I | Z-0627-2022 | Process change control | The firm received reports indicating PTD tip separation during use. |
| Jan 11, 2022 | Class I | Z-0628-2022 | Process change control | The firm received reports indicating PTD tip separation during use. |
| Sep 20, 2021 | Class I | Z-0233-2022 | Unknown/Undetermined by firm | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. |
| Sep 20, 2021 | Class I | Z-0234-2022 | Unknown/Undetermined by firm | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. |
| Sep 20, 2021 | Class I | Z-0231-2022 | Unknown/Undetermined by firm | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. |
| Sep 20, 2021 | Class I | Z-0232-2022 | Unknown/Undetermined by firm | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. |
| Feb 11, 2009 | Not classified | Z-1502-2009 | 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. |
| Mar 18, 2005 | Not classified | Z-0842-05 | Other | The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QEW devicesQEW Peripheral Mechanical Thrombectomy With Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QEW
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEW
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEW
7in 2022
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · QEW
207in 2025
MAUDE reports naming product code QEW, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 4 | 88 | 0 | 0 |
| 2016 | 4 | 63 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 14 | 61 | 0 | 0 |
| 2019 | 8 | 51 | 0 | 33 |
| 2020 | 16 | 105 | 0 | 197 |
| 2021 | 11 | 60 | 0 | 322 |
| 2022 | 12 | 140 | 7 (7) | 125 |
| 2023 | 23 | 102 | 0 | 165 |
| 2024 | 14 | 65 | 0 | 162 |
| 2025 | 14 | 58 | 0 | 207 |
| 2026 | 10 | 74 | 0 | — |
What is it indicated for?
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and 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/K011056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011056: Arrow-Trerotola Percutaneous Thrombolytic Device or PTD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011056
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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