MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE— 510(k) K893633

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K893633 for MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE, Substantially Equivalent on 1989-06-20. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DTE
Advisory panel: Cardiovascular
Date received: 1989-05-11
Decision date: 1989-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.