MEDTRONIC S3 TM SYSTEM— 510(k) K821004

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K821004 for MEDTRONIC S3 TM SYSTEM, Substantially Equivalent on 1982-05-25. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1982-04-09
Decision date: 1982-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.