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Access Vascular Receives FDA Clearance for HydroPICC Catheter
Devices Regulatory Affairs
Access Vascular received 510(k) marketing clearance from the FDA for its lead product, the HydroPICC, a peripherally inserted central catheter intended for long-term use.
In pre-clinical testing, the HydroPICC demonstrated a 30x reduction in platelet count when compared with current catheters, the company said.
To meet the anticipated demand for the HydroPICC, Access Vascular is expanding its manufacturing and testing facility with an additional 4,000-square foot laboratory and manufacturing space.