FDA 510(k) Applications for Medical Device Product Code "KNX"
(Collector, Urine, (And Accessories) For Indwelling Catheter)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K964745 |
AMSINO INTL., INC. |
AMSINO URINARY DRAINAGE BAG |
03/18/1997 |
K971929 |
AMSINO INTL., INC. |
AMSINO URINARY LEG BAG |
08/06/1997 |
K960949 |
BRISTOL-MYERS SQUIBB |
PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 |
04/19/1996 |
K964690 |
CLEVELAND MEDICAL DEVICES, INC. |
LIBERTY VALVE |
03/21/1997 |
K962652 |
CUSTOMED, INC. |
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) |
10/04/1996 |
K110518 |
FUTURE PATH MEDICAL, LLC |
IBAG |
06/24/2011 |
K973364 |
MAERSK MEDICAL A/S |
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG |
03/17/1998 |
K972887 |
MEDLINE INDUSTRIES, INC. |
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG |
12/11/1997 |
K971271 |
UROLOGY RESEARCH INTL., INC. |
BESECURE EXTERNAL URINARY COLLECTION SYSTEM |
08/18/1997 |
K971764 |
WELCON, INC. |
WELCON HUE-VU URINARY DRAINAGE BAG |
07/29/1997 |
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