BD PosiFlush Heparin Lock Flush Syringe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163591 FDA 510(k)
- FDA Product Code
- NZW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD PosiFlush Heparin Lock Flush Syringe is a prefilled, single-use vascular access flush device designed to maintain catheter patency. It contains heparin in two concentrations (10 USP units/mL or 100 USP units/mL) to lock vascular access devices, reducing the risk of clotting and contamination.
Available in 3 mL and 5 mL sizes, the device is supplied sterile and is intended for single-use in hospital settings. It is classified as a Class II medical device under FDA regulations, with clearance via a Special 510(k) pathway (K163591). Storage and handling follow standard aseptic protocols for prefilled syringes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD PosiFlush™ Heparin Lock Flush Syringe | Catheter Patency | BD, BD PosiFlush™ Prefilled Heparin Lock Flush Syringe, BD PosiFlush™ Prefilled Heparin Lock Flush Syringe, 5mL, 100 USP 30/BX, BD (company) - Wikipedia, BD PosiFlush™ Heparin Lock Flush Syringe | Catheter Patency | BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163591 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K163591 24 fields · synced Sep 18, 2026