BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD— 510(k) K993816

Substantially Equivalent

Baxter Edwards

FDA 510(k) clearance K993816 for BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD, Substantially Equivalent on 2000-05-04. Applicant: Baxter Edwards.

Clearance details

Applicant: Baxter Edwards
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 1999-11-10
Decision date: 2000-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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, 2020-01-01 through 2026-04-23. 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.