PRESSURE GAUGE ACCESSORY KIT/DILATATION— 510(k) K802261

Substantially Equivalent

Stanco Medical, Inc.

FDA 510(k) clearance K802261 for PRESSURE GAUGE ACCESSORY KIT/DILATATION, Substantially Equivalent on 1980-10-03. Applicant: Stanco Medical, Inc..

Clearance details

Applicant: Stanco Medical, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1980-09-16
Decision date: 1980-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.