MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS— 510(k) K894055

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K894055 for MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS, Substantially Equivalent on 1989-08-25. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1989-06-07
Decision date: 1989-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

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.