510(k) K022110

KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. by Kawasumi Laboratories, Inc. — Product Code LJT

K022110 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories, Inc. for the device "KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.". The FDA issued a decision of Substantially Equivalent on September 12, 2002. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Kawasumi Laboratories, Inc. has at least 10 other 510(k) clearances on record.