MEDTRONIC CATHETER ACCESS PORT MODEL 8500— 510(k) K873735

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K873735 for MEDTRONIC CATHETER ACCESS PORT MODEL 8500, Substantially Equivalent on 1987-11-03. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1987-09-15
Decision date: 1987-11-03
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.