VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE— 510(k) K945952
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K945952 for VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE, Substantially Equivalent on 1995-01-18. 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 K945952
K-number listed on FDA's recall record- Z-2300-2019 — BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
- Z-2301-2019 — BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
- Z-2302-2019 — BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
- Z-2303-2019 — BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
- Z-2304-2019 — BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
- Z-2305-2019 — BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
- Z-2308-2019 — BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
- Z-1746-2017 — BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
- Z-1189-2017 — BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations
- Z-0911-2013 — BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945952.
Data sourced from openFDA. This site is unofficial and independent of the FDA.