AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)— 510(k) K971984

Substantially Equivalent

Microvena Corp.

FDA 510(k) clearance K971984 for AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200), Substantially Equivalent on 1997-09-19. Applicant: Microvena Corp..

Clearance details

Applicant: Microvena Corp.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 1997-05-29
Decision date: 1997-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Bear Lake, MN, 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.