510(k) · Cleared
ClearedBaxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Edwards · MCW Catheter, Peripheral, Atherectomy
Cleared on May 4, 2000 after a 176-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- May 4, 2000
- Review
- 176 days
- Class
- Class II
- Product code
- MCW
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK993816 Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models…Baxter Edwards · 2000
- Descendant · cites it directly · 6 of its ownK021096 X-Sizer Catheter SystemEv3 Corporation · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK120508 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012
- Descendant · cites it directly · 3 of its ownK041705 Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies · 2004
- Descendant · 3 generations on · 2 of its ownK140296 Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK052428 Resolution Endovascular SystemOmnisonics Medical Technologies · 2005
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K021096X-Sizer Catheter SystemEv3 Corporation · 2004 · cites it directly6descendants
- K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2012 · 2 generations on3descendants
- K041705Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies · 2004 · cites it directly3descendants
- K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC · 2014 · 3 generations on2descendants
- K052428Resolution Endovascular SystemOmnisonics Medical Technologies · 2005 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993816 | Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and… | Baxter Edwards | 2000 | — |
| +1 | K021096 | X-Sizer Catheter System | Ev3 Corporation | 2004 | 2 |
| +2 | K120508 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2012 | — |
| +1 | K041705 | Resolution Thrombectomy System, Model EV-2 | Omnisonics Medical Technologies | 2004 | — |
| +3 | K140296 | Clearlumen Thrombectomy System | Walk Vascular, LLC | 2014 | — |
| +2 | K052428 | Resolution Endovascular System | Omnisonics Medical Technologies | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | — | MICROVENA Amplatz Thrombectomy Device (ATD) Named without a submission number |
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? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021096 (Ev3 Corporation, 2004) has gone furthest, with 6 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?
Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is indicated for
removal of thrombus in synthetic dialysis 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/K993816 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993816: Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993816
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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