FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K112734 |
APLAN WELL ENTERPRISE CO., LTD |
APLAN A.V. FISTULA NEEDLE SET |
04/24/2012 |
K163025 |
Bain Medical Equipment (Guangzhou) Co., Ltd. |
DORA Disposable A.V. Fistula Needle Sets |
07/20/2017 |
K213015 |
Bain Medical Equipment (Guangzhou)Co., Ltd. |
DORA Disposable A.V. Fistula Needle Sets |
04/08/2022 |
K993118 |
BIOTEQUE CORP. |
BIOTEQUE A.V. FISTULA NEEDLE SET |
12/17/1999 |
K992653 |
DIASOL, INC. |
SHELLY PROTECTED AV FISTULA NEEDLE |
10/27/1999 |
K171505 |
Dimesol, Inc. |
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) |
05/17/2018 |
K001496 |
EXELINT INTERNATIONAL CO. |
A.V. FISTULA NEEDLE |
08/01/2000 |
K013037 |
EXELINT INTL. CO. |
EXCEL A.V FISUTAL NEEDLE SET |
12/07/2001 |
K023162 |
FRESENIUS MEDICAL CARE |
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS |
03/20/2003 |
K990470 |
JMS CO., LTD. |
JMS A. V. FISTULA NEEDLE SET |
08/30/1999 |
K002352 |
JMS CO., LTD. |
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE |
09/06/2001 |
K974902 |
JMS CO., LTD. |
JMS APHERESIS NEEDLE |
03/30/1998 |
K990510 |
JMS CO., LTD. |
JMS APHERESIS NEEDLE |
08/30/1999 |
K970962 |
JMS CO., LTD. |
JMS AV FISTULA NEEDLE |
08/07/1997 |
K000845 |
JMS CO., LTD. |
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET |
04/10/2000 |
K000843 |
JMS CO., LTD. |
MODIFICATION TO JMS APHERESIS NEEDLE |
04/10/2000 |
K082882 |
JMS NORTH AMERICA CORP. |
A.V. FISTULA BLUNT NEEDLE SET |
01/21/2009 |
K093637 |
JMS NORTH AMERICA CORP. |
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 |
02/09/2010 |
K051814 |
JMS NORTH AMERICA CORP. |
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET |
08/04/2005 |
K040247 |
JMS NORTH AMERICA CORP. |
PLUME SAFETY AVF NEEDLE |
03/03/2004 |
K112178 |
JMS NORTH AMERICA CORPORATION |
JMS APHERESIS NEEDLE SET WINGEATER(R) V2 |
10/27/2011 |
K151017 |
JMS NORTH AMERICA CORPORATION |
JMS Harmony A.V. Fistula Needle Set |
05/13/2015 |
K142564 |
JMS North America Corporation |
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) |
12/23/2014 |
K110157 |
JMS NORTH AMERICA CORPORATION |
SYSLOC MINI V3 |
02/11/2011 |
K111948 |
JMS NORTH AMERICA CORPORATION |
WINGEATER V2 |
10/24/2011 |
K062953 |
MEDISYSTEMS CORP. |
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE |
02/12/2007 |
K990803 |
MEDISYSTEMS CORP. |
MEDISYSTEMS BUTTONHOLE NEEDLE SETS |
01/06/2000 |
K991623 |
NIPRO MEDICAL CORP. |
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA |
08/09/1999 |
K063368 |
NIPRO MEDICAL CORP. |
NIPRO BIOHOLE NEEDLE |
02/05/2007 |
K063721 |
NIPRO MEDICAL CORP. |
NIPRO SAFETOUCH II GAMMA |
01/12/2007 |
K093985 |
NIPRO MEDICAL CORP. |
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE |
01/22/2010 |
K002813 |
NIPRO MEDICAL CORP. |
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE |
11/21/2000 |
K100520 |
NIPRO MEDICAL CORPORATION |
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER |
03/17/2010 |
K955182 |
NISSHO CORP. |
NIPRO ARTERIAL VENOUS FISTULA NEEDLE |
06/04/1996 |
K134019 |
NXSTAGE MEDICAL, INC. |
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO |
09/11/2014 |
K013384 |
SHARGH PHARMACEUTICAL CO., INC. |
SHARGHP A.V. FISTULA NEEDLE SET |
01/07/2002 |
K131950 |
SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. |
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET |
01/16/2015 |
K003123 |
SUNDER BIOMEDICAL TECH. CO., LTD. |
RENAX A.V. FISTULA NEEDLE SETS |
05/04/2001 |
K052267 |
TOGO MEDIKIT CO., LTD. |
SUPERCATH V |
10/27/2006 |