DeviceClearance

K232737

Substantially Equivalent

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

Applicant
Bard Peripheral Vascular, Inc.
Product code
LJT
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Tempe, AZ, US
Download summary PDF View on FDA.gov ↗

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, through . 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.