FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K961361 |
A+ PRODUCTS |
ASTA-CATH |
10/31/1996 |
K011552 |
APOGEE MEDICAL, INC. |
UROLOGICAL CATHETER |
07/18/2001 |
K992137 |
APOGEE, INC. |
UROLOGICAL CATHETER |
09/03/1999 |
K050874 |
ASTRA TECH, INC. |
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER |
05/05/2005 |
K043241 |
ASTRA TECH, INC. |
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER |
12/23/2004 |
K012374 |
ASTRA TECH, INC. |
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER |
08/23/2001 |
K180801 |
B. Braun Medical Inc. |
Actreen Hi-Lite Cath, Actreen Hi-Lite Set |
11/05/2018 |
K192577 |
B. Braun Medical Inc. |
Actreen Hi-Lite Intermittent Urinary Catheters |
05/07/2020 |
K151772 |
B. BRAUN MEDICAL INC. |
Actreen Mini Intermittent Urinary Catheters |
02/09/2016 |
K965067 |
BOSTON SCIENTIFIC CORP. |
DILATION CATHETER, BALLOON |
01/28/1997 |
K060268 |
CLAY KENNARD |
PEDIATRIC URINARY CATHETER |
02/24/2006 |
K192904 |
Coloplast |
SpeediCath Compact Set |
11/02/2020 |
K200820 |
Coloplast |
SpeediCath Compact Set |
11/13/2020 |
K180070 |
Coloplast |
SpeediCath Flex Coude Pro |
02/02/2018 |
K190620 |
Coloplast |
SpeediCath Flex Coude Pro |
07/10/2019 |
K200142 |
Coloplast |
SpeediCath Soft |
07/30/2020 |
K180258 |
Coloplast |
SpeediCath Standard |
10/25/2018 |
K150935 |
COLOPLAST A/S |
SpeediCath Compact Eve |
07/02/2015 |
K143182 |
COLOPLAST A/S |
Speedicath Compact Male |
01/20/2015 |
K121458 |
COLOPLAST A/S |
SPEEDICATH COMPACT SET (12/18 FR) |
10/01/2012 |
K023254 |
COLOPLAST CORP. |
SPEEDICATH |
01/27/2003 |
K072808 |
COLOPLAST CORP. |
SPEEDICATH COMPACT |
11/09/2007 |
K121457 |
COLOPLAST CORP. |
SPEEDICATH COMPACT SET (12 FR) |
10/02/2012 |
K161672 |
Coloplast Corp. |
SpeediCath Flex Coude |
09/29/2016 |
K213283 |
ConvaTec Limited |
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter |
06/22/2022 |
K181206 |
ConvaTec Limited |
GentleCath Glide Intermittent Urinary Catheter |
08/16/2018 |
K172278 |
Cook Incorporated |
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent |
11/22/2017 |
K182511 |
F&S Medical Solutions, LLC |
SimplCath |
03/20/2019 |
K101900 |
HAKKI MEDICAL TECHNOLOGIES, INC. |
HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH |
02/07/2011 |
K191512 |
Hakki Medical Technologies, Inc. |
LotusCatheter (Lotus No Balloon Catheter) |
05/21/2020 |
K111405 |
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, |
02/13/2012 |
K192468 |
Hangzhou Bever Medical Devices Co., Ltd. |
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, O |
11/27/2019 |
K200134 |
Hangzhou Jimushi Meditech Co., Ltd. |
Jimushi Sterile Urethral Catheter for single use |
06/01/2020 |
K191633 |
Hollister Incorporated |
Infyna Chic |
07/19/2019 |
K211436 |
Hollister Incorporated |
Intermittent Catheter (Not Finalized) |
01/27/2022 |
K163179 |
HOLLISTER INCORPORATED |
Onli Intermittent Catheter |
01/26/2017 |
K183253 |
Hollister Incorporated |
ValPro 2 Plus, VaPro 2 Plus Pocket |
12/18/2018 |
K180824 |
Hollister Incorporated |
VaPro 2 Intermittent Catheter |
06/22/2018 |
K152268 |
HOLLISTER INCORPORATED |
VAPRO PLUS POCKET Intermittent Catheter |
09/09/2015 |
K193148 |
Hollister Incorporated |
VaPro Plus Pocket, VaPro Plus |
12/13/2019 |
K143594 |
Hollister Incorporated |
VaPro Pocket |
01/09/2015 |
K090960 |
HOLLISTER, INC. |
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, |
08/20/2009 |
K141642 |
HOLLISTER, INCORPORATED |
VAPRO INTERMITTENT CATHETER |
08/22/2014 |
K110862 |
HOLLISTER, INCORPORATED |
VAPRO PLUS INTERMITTENT CATHETER |
04/26/2011 |
K063795 |
MARIAN MEDICAL, INC. |
GUARDIANCATHETER-URINARY DRAINAGE CATHETER |
03/05/2007 |
K973120 |
MEDICAL TECHNOLOGIES OF GEORGIA |
READYCATH CATHETER |
02/25/1998 |
K031409 |
PROMEDIC, INC. |
URINARY CATHETERS |
06/17/2003 |
K160795 |
ROBLING MEDICAL |
United Urologics Intermittent Catheter |
06/16/2016 |
K970704 |
ROCHESTER MEDICAL CORP. |
PERSONAL CATHETER |
03/13/1997 |
K020714 |
RUSCH INTL. |
RUSCH FLONEIL; FLOCATH INTROGEL |
07/01/2002 |
K993651 |
SC HENNIG ENTERPRISES EUROPE SRL |
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER |
12/23/1999 |
K183461 |
Teleflex Medical, Inc |
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter |
05/08/2019 |
K142767 |
ThinkMed Medical Technology Co., Ltd. |
ThinkMed Intermittent Catheter with/without Hydrophilic Coating |
02/03/2015 |
K021938 |
VITALCARE, INC. |
VITALCARE URETHRAL CATHETER |
04/22/2003 |