AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100— 510(k) K982657

Name: FDA 510(k) clearance K982657
Creator: U.S. Food and Drug Administration
Published: 1998-11-18

Substantially Equivalent

Microvena Corp.

FDA 510(k) clearance K982657 for AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100, Substantially Equivalent on 1998-11-18. Applicant: Microvena Corp.. Device class: 2.

Clearance details

Applicant: Microvena Corp.
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 1998-07-30
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Bear Lake, MN, US

Download summary PDF View on FDA.gov ↗

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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.