FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K072354 |
ACCELLENT INC. |
GUIDEWIRE, MODEL G-V220-3527S AND OTHERS |
12/07/2007 |
K141820 |
BOSTON SCIENTIFIC CORP. |
JAGWIRE HIGH PERFORMANCE GUIDWIRE |
10/21/2014 |
K964780 |
C.R. BARD, INC. |
BARD DIRECTOR GUIDEWIRE (000560) |
02/26/1997 |
K962178 |
C.R. BARD, INC. |
BARD TIGER GUIDEWIRE MODEL 000540 |
10/29/1996 |
K131072 |
COLOPLAST A/S |
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC |
07/09/2013 |
K150927 |
COLOPLAST A/S |
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff |
05/27/2015 |
K050304 |
CONMED CORP. |
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE |
03/08/2005 |
K082536 |
COOK UROLOGICAL, INC. |
COOK WIRE GUIDES |
10/27/2008 |
K023603 |
ENDO-THERAPEUTICS, INC. |
ENDO-GLIDE GUIDEWIRE |
02/19/2003 |
K990765 |
FLEXMEDICS |
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO |
03/15/1999 |
K964955 |
FLEXMEDICS |
FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING |
02/14/1997 |
K140482 |
LAKE REGION MEDICAL |
MANDREL GUIDEWIRE |
04/08/2014 |
K080508 |
LAKE REGION MEDICAL |
MANDREL GUIDEWIRES OR M-WIRE |
03/21/2008 |
K124052 |
LAKE REGION MEDICAL |
OSTAVI HYDROPHILIC GUIDEWIRE |
02/26/2013 |
K142397 |
Lake Region Medical |
Predicate III Guidewire |
09/19/2014 |
K081708 |
LAKE REGION MFG., INC. |
TAXI ENDOSCOPIC GUIDEWIRE |
08/26/2008 |
K153264 |
MEDI-GLOBE CORPORATION |
EasyPass Guidewire |
05/19/2016 |
K123439 |
NEOMETRICS, INC. |
NEO ERCP GUIDEWIRE |
01/03/2013 |
K133076 |
NEOMETRICS, INC. |
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE |
02/20/2014 |
K150225 |
NEOMETRICS, INC. |
NovaGold High Performance Guidewire |
03/16/2015 |
K060034 |
NIPRO MEDICAL CORPORATION |
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE |
02/28/2006 |
K021179 |
OLYMPUS OPTICAL CO., LTD. |
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A |
07/05/2002 |
K011759 |
RADIUS MEDICAL TECHNOLOGIES, INC. |
RADIUS NEXT GENERATION GUIDEWIRE |
08/23/2001 |
K053028 |
TECHDEVICE CORPORATION |
TECHDEVICE GUIDEWIRE |
01/31/2006 |
K091417 |
TERUMO CORP. |
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A |
05/22/2009 |
K971937 |
TERUMO MEDICAL CORP. |
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE |
08/15/1997 |
K151471 |
Terumo Medical Corporation |
Radifocus Glidewire Endoscopic Wire |
09/17/2015 |
K122816 |
WILSON-COOK MEDICAL INC. |
AXCESS SOFT TIP WIRE GUIDE |
10/09/2012 |
K142950 |
Wilson-Cook Medical, Inc |
Acrobat Calibrated Tip Wire Guide |
11/05/2014 |
K033754 |
WILSON-COOK MEDICAL, INC. |
TRACER METRO SMART WIRE GUIDE |
12/30/2003 |
K040137 |
WILSON-COOK MEDICAL, INC. |
WILSON-COOK USW CAP AND WIRE LOCK |
02/20/2004 |
K113692 |
XENOLITH MEDICAL |
XENX |
08/09/2012 |
K123438 |
XENOLITH MEDICAL |
XENX STONE MANAGEMENT DEVICE |
01/10/2013 |