BD VIPER LT SYSTEM— 510(k) K140447
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K140447 for BD VIPER LT SYSTEM, Substantially Equivalent on 2014-05-20. Applicant: Becton, Dickinson and Company. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code OOI
- Device class
- Class 2
- Regulation
- 21 CFR 862.2570
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code OOI
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view all- 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
- K260184 — Onclarity Self-Collection Kit
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
Adverse events under product code OOI
product code OOI- Malfunction
- 2,506
- Other
- 3
- Total
- 2,509
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 K140447
K-number listed on FDA's recall record- Z-1866-2017 — BD Viper LT software, version 3.00H
- Z-1816-2015 — BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140447.
Data sourced from openFDA. This site is unofficial and independent of the FDA.