510(k) K952058

STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE by Trinity Laboratories, Inc. — Product Code FOZ

K952058 is an FDA 510(k) premarket notification submitted by Trinity Laboratories, Inc. for the device "STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on September 21, 1995. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Trinity Laboratories, Inc. has at least 10 other 510(k) clearances on record.