Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port— 510(k) K252478

Substantially Equivalent

Bard Access Systems, Inc.

FDA 510(k) clearance K252478 for Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port, Substantially Equivalent on 2025-09-05. Applicant: Bard Access Systems, Inc..

Clearance details

Applicant: Bard Access Systems, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2025-08-07
Decision date: 2025-09-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake Ciy,, UT, 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.