PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports— 510(k) K242328
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K242328 for PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports, Substantially Equivalent on 2024-10-31. Applicant: Bard Access Systems, Inc..
Clearance details
- Applicant
- Bard Access Systems, Inc.
- Product code
- Code LJT
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake Ciy,, UT, US
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.