JET PORT PLUS CATHETER SYSTEM— 510(k) K000125
Substantially EquivalentClinical Plastic Products SA
FDA 510(k) clearance K000125 for JET PORT PLUS CATHETER SYSTEM, Substantially Equivalent on 2000-04-12. Applicant: Clinical Plastic Products SA.
Clearance details
- Applicant
- Clinical Plastic Products SA
- Product code
- Code LJT
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Santa Margarita, CA, 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.