DeviceClearance

K993816

Substantially Equivalent

BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD

Applicant
Baxter Edwards
Product code
MCW
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW
Death
38
Injury
1,386
Malfunction
2,676
Other
2
Total
4,102

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.