E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS— 510(k) K952053
Substantially EquivalentBecton Dickinson Vascular Access, Inc.
FDA 510(k) clearance K952053 for E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS, Substantially Equivalent on 1995-05-31. Applicant: Becton Dickinson Vascular Access, Inc..
Clearance details
- Applicant
- Becton Dickinson Vascular Access, Inc.
- Product code
- Code FPA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandy, UT, US
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.