30 ML OR 60 ML PEDI-SYRINGE FILTER— 510(k) K050805
Substantially EquivalentBlood Products Specialties, LLC
FDA 510(k) clearance K050805 for 30 ML OR 60 ML PEDI-SYRINGE FILTER, Substantially Equivalent on 2005-06-20. Applicant: Blood Products Specialties, LLC. Device class: 2.
Clearance details
- Applicant
- Blood Products Specialties, LLC
- Product code
- Code BRZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oceanside, NY, US
Recent devices under product code BRZ
view allAdverse events under product code BRZ
product code BRZ- Malfunction
- 458
- Total
- 458
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 K050805
K-number listed on FDA's recall record- Z-2667-2014 — Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
- Z-2668-2014 — Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
- Z-2669-2014 — Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050805.
Data sourced from openFDA. This site is unofficial and independent of the FDA.