PS MEDICAL IPI VASCULAR ACCESS CATHETER— 510(k) K954409
Substantially EquivalentPudenz-Schulte Medical Research Corp.
FDA 510(k) clearance K954409 for PS MEDICAL IPI VASCULAR ACCESS CATHETER, Substantially Equivalent on 1995-12-18. Applicant: Pudenz-Schulte Medical Research Corp..
Clearance details
- Applicant
- Pudenz-Schulte Medical Research Corp.
- Product code
- Code LJS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.