VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET— 510(k) K062414

Substantially Equivalent

Rita Medical Systems, Inc.

FDA 510(k) clearance K062414 for VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET, Substantially Equivalent on 2007-02-01. Applicant: Rita Medical Systems, Inc..

Clearance details

Applicant: Rita Medical Systems, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2006-08-17
Decision date: 2007-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, GA, 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.