NORCATH VASCULAR ACCESS CATHETERS— 510(k) K911067

Substantially Equivalent

Norfolk Medical

FDA 510(k) clearance K911067 for NORCATH VASCULAR ACCESS CATHETERS, Substantially Equivalent on 1991-06-03. Applicant: Norfolk Medical.

Clearance details

Applicant: Norfolk Medical
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1991-03-11
Decision date: 1991-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.