FDA 510(k) Applications Submitted by KAWASUMI LABORATORIES, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K123344 10/31/2012 K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) KAWASUMI LABORATORIES, INC.
K022110 06/28/2002 KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. KAWASUMI LABORATORIES, INC.
K023917 11/25/2002 WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR KAWASUMI LABORATORIES, INC.
K060580 03/06/2006 K-SHIELD PORT ACCESS INFUSION SET KAWASUMI LABORATORIES, INC.
K102994 10/08/2010 K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR KAWASUMI LABORATORIES, INC.
K073257 11/19/2007 KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR KAWASUMI LABORATORIES, INC.
K190233 02/06/2019 K-Shield Advantage Port Access Infusion Set (PAIS) Kawasumi Laboratories, Inc.
K190485 02/27/2019 Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) Kawasumi Laboratories, Inc.
K100720 03/15/2010 K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING KAWASUMI LABORATORIES, INC.
K061197 04/28/2006 KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER KAWASUMI LABORATORIES, INC.
K172957 09/26/2017 Kawasumi Laboratories Blood Drawing Kit (BDK) System Kawasumi Laboratories, Inc.


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