30 ML OR 60 ML PEDI-SYRINGE FILTER
FDA 510(k) clearance K050805 · decided 2005-06-20
Clearance details
- K-number
- K050805
- Device name
- 30 ML OR 60 ML PEDI-SYRINGE FILTER
- Applicant
- Blood Products Specialties, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-03-30
- Decision date
- 2005-06-20
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- BRZ
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Oceanside, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The i recall (Z-2667-2014) | Genesis BPS, LLC. | 2014-09-18 |
| Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, recall (Z-2668-2014) | Genesis BPS, LLC. | 2014-09-18 |
| Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended recall (Z-2669-2014) | Genesis BPS, LLC. | 2014-09-18 |