IPI IMPORT— 510(k) K922419
Substantially EquivalentPudenz-Schulte Medical Research Corp.
FDA 510(k) clearance K922419 for IPI IMPORT, Substantially Equivalent on 1992-11-20. Applicant: Pudenz-Schulte Medical Research Corp.. Device class: 2.
Clearance details
- Applicant
- Pudenz-Schulte Medical Research Corp.
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code LJT
view all- K260916 — FLEXI-PORT Power Injectable Implantable Port
- K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port +2 more
- K251253 — PowerPort isp Implantable Port +3 more
- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
More clearances from Pudenz-Schulte Medical Research Corp.
view allAdverse 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.