FDA Grants Additional Clearance for Velano’s Blood Draw Device
Velano Vascular has received FDA clearance for a modified version of its needle-free blood draw device.
This second 510(k) clearance covers two modifications designed to enhance the product’s usability for inpatient blood draws: The addition of a clamp for use with syringe draws and a refinement to the indication for use.
The Velano device is attached to a peripheral IV catheter to draw blood directly into a vacuum tube or a syringe. The revised IFU removes a limitation in the earlier clearance that specified when the device could be used with in-dwelling peripheral IV catheters.
The device is designed to reduce blood draw-related discomfort and anxiety for patients, provide a safer work environment for healthcare providers and standardize today’s fragmented approaches to inpatient blood draws, Velano says. — Jonathon Shacat