510(k) K984055

CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS by Sims Deltec, Inc. — Product Code FOZ

K984055 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS". The FDA issued a decision of Substantially Equivalent on January 29, 1999. 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. Sims Deltec, Inc. has at least 10 other 510(k) clearances on record.