OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY— 510(k) K905646

Substantially Equivalent

Norfolk Medical

FDA 510(k) clearance K905646 for OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY, Substantially Equivalent on 1991-03-27. Applicant: Norfolk Medical.

Clearance details

Applicant: Norfolk Medical
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1990-12-17
Decision date: 1991-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, 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.