MEDTRONIC MODEL 546— 510(k) K782108

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K782108 for MEDTRONIC MODEL 546, Substantially Equivalent on 1978-12-29. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DTE
Advisory panel: Cardiovascular
Date received: 1978-12-19
Decision date: 1978-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.