PORT-A-CATH IMPLANTABLE CATH. SYS— 510(k) K830730
Substantially EquivalentPharmacia, Inc.
FDA 510(k) clearance K830730 for PORT-A-CATH IMPLANTABLE CATH. SYS, Substantially Equivalent on 1983-06-30. Applicant: Pharmacia, Inc..
Clearance details
- Applicant
- Pharmacia, Inc.
- Product code
- Code LJT
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, 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.