B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204— 510(k) K912330
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K912330 for B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204, Substantially Equivalent on 1991-10-11. 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.