STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)— 510(k) K972728
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K972728 for STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS), Substantially Equivalent on 1998-07-15. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Recent devices under product code FMF
view allMore clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic
view allAdverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.