MEDTRONIC MODEL 8501 ACCESS PORT— 510(k) K861498

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K861498 for MEDTRONIC MODEL 8501 ACCESS PORT, Substantially Equivalent on 1986-06-12. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1986-04-23
Decision date: 1986-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.