# K993816: Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Edwards
- Decided: May 4, 2000 after 176 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MICROVENA Amplatz Thrombectomy Device (ATD): named in the summary without a submission number

## Most influential descendants
- K021096: X-Sizer Catheter System (2004), 6 descendants of its own
- K120508: Clearlumen Thrombectomy System (2012), 3 descendants of its own
- K041705: Resolution Thrombectomy System, Model EV-2 (2004), 3 descendants of its own
- K140296: Clearlumen Thrombectomy System (2014), 2 descendants of its own
- K052428: Resolution Endovascular System (2005), 2 descendants of its own

## Indications for use
Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is indicated for removal of thrombus in synthetic dialysis access grafts.

Source page: https://510kreport.com/device/K993816
Methodology: https://510kreport.com/methodology