K780952

Substantially Equivalent

MODEL 1812 CONTROL CONSOLE, ACCESSORIEX

Applicant: Medtronic Vascular
Product code: DWA
Advisory panel: Cardiovascular
Date received: 1978-06-09
Decision date: 1978-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.