Kawasumi Laboratories Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: KAWASUMI LABORATORIES PHILEBOTOMY SET, NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET), NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kawasumi Laboratories Co., Ltd. General Hospital ✕
15 devices
Cleared
Mar 08, 2000
KAWASUMI LABORATORIES PHILEBOTOMY SET
General Hospital
77d
Cleared
Feb 12, 1998
NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
General Hospital
50d
Cleared
Mar 14, 1997
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
General Hospital
150d
Cleared
Feb 10, 1994
VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
General Hospital
86d
Cleared
Feb 03, 1994
WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER
General Hospital
79d
Cleared
Feb 03, 1994
MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
General Hospital
79d
Cleared
Dec 14, 1993
KAWASUMI LABORATORIES K-CUFF
General Hospital
344d
Cleared
Sep 10, 1993
PORT ACCESS INFUSION SET
General Hospital
506d
Cleared
Jul 28, 1993
PORT ACCESS NEEDLE
General Hospital
462d
Cleared
Jul 13, 1993
INTERMITTENT INJECTION SITE
General Hospital
371d
Cleared
Sep 12, 1990
KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
General Hospital
278d
Cleared
Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE
General Hospital
278d