Kawasumi Laboratories Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K994323KAWASUMI LABORATORIES PHILEBOTOMY SETMarch 8, 2000
K974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)February 12, 1998
K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITEMarch 14, 1997
K935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDERFebruary 10, 1994
K935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTIONFebruary 3, 1994
K935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTERFebruary 3, 1994
K930012KAWASUMI LABORATORIES K-CUFFDecember 14, 1993
K921901PORT ACCESS INFUSION SETSeptember 10, 1993
K921902PORT ACCESS NEEDLEJuly 28, 1993
K923323INTERMITTENT INJECTION SITEJuly 13, 1993
K896895KAWASUMI I.V. ADMINISTRATION SETSeptember 12, 1990
K896893KAWASUMI I.V. ADMINISTRATION SET WITH BURETTESeptember 12, 1990
K896896KAWASUMI SMALL VEIN INFUSION SETSeptember 12, 1990
K896892KAWASUMI Y-TYPE BLOOD ADMINISTRATION SETSeptember 12, 1990
K896894KAWASUMI BLOOD ADMINISTRATION SETSeptember 12, 1990
K883748RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERSJanuary 31, 1989
K873421KAWASUMI A.V. FISTULA SETOctober 9, 1987
K873516KAWASUMI BLOOD TUBING LINEOctober 5, 1987