510(k) K182243

The CVC WAND Safety Introducer with Valved Peelable Sheath by Access Scientific, LLC — Product Code DYB

K182243 is an FDA 510(k) premarket notification submitted by Access Scientific, LLC for the device "The CVC WAND Safety Introducer with Valved Peelable Sheath". The FDA issued a decision of Substantially Equivalent on September 18, 2018. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Access Scientific, LLC has at least 10 other 510(k) clearances on record.