PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port— 510(k) K232737

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K232737 for PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port, Substantially Equivalent on 2023-12-08. Applicant: Bard Peripheral Vascular, Inc..

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2023-09-07
Decision date: 2023-12-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, 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.