VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE— 510(k) K944566
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K944566 for VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE, Substantially Equivalent on 1994-11-10. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Recent devices under product code JKA
view all- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
- K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes
- K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
More clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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 →
Recalls naming K944566
K-number listed on FDA's recall record- Z-2306-2019 — BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
- Z-2307-2019 — BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944566.
Data sourced from openFDA. This site is unofficial and independent of the FDA.