FDA 510(k) Applications for Medical Device Product Code "NLH"
(Catheter, Recording, Electrode, Reprocessed)

FDA 510(k) Number Applicant Device Name Decision Date
K012708 ALLIANCE MEDICAL CORP. ELECTROPHYSIOLOGY CATHETER 08/13/2002
K030109 ALLIANCE MEDICAL CORP. ELECTROPHYSIOLOGY CATHETER 08/08/2003
K052603 ALLIANCE MEDICAL CORP. REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS 11/16/2005
K030026 ALLIANCE MEDICAL CORP. REPROCESSED ELECTROPHYSIOLOGY CATHETER 05/02/2003
K030279 ALLIANCE MEDICAL CORP. REPROCESSED ELECTROPHYSIOLOGY CATHETER 10/03/2003
K052414 ALLIANCE MEDICAL CORP. REPROCESSED ELECTROPHYSIOLOGY CATHETER 11/16/2005
K043392 ALLIANCE MEDICAL CORP. REPROCESSED ELECTROPHYSIOLOGY CATHETERS 03/25/2005
K061045 ALLIANCE MEDICAL CORP. REPROCESSED ELECTROPHYSIOLOGY CATHETERS 08/31/2006
K043393 ALLIANCE MEDICAL CORP. REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS 03/23/2005
K030187 ALLIANCE MEDICAL, INC. REPROCESSED ELECTROPHYSIOLOGY CATHETER 09/24/2003
K100254 ASCENT HEALTHCARE SOLUTIONS REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER 05/28/2010
K081329 ASCENT HEALTHCARE SOLUTIONS REPROCESSED ELECTROPHYSIOLOGY CATHETERS 07/09/2008
K082023 ASCENT HEALTHCARE SOLUTIONS REPROCESSED ELECTROPHYSIOLOGY CATHETERS 09/16/2008
K090323 ASCENT HEALTHCARE SOLUTIONS REPROCESSED ELECTROPHYSIOLOGY CATHETERS 04/01/2009
K161464 Innovative Health, LLC Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters 09/30/2016
K153153 INNOVATIVE HEALTH, LLC Reprocessed Electrophysiology Catheter 03/14/2016
K160242 INNOVATIVE HEALTH, LLC Reprocessed Livewire Steerable Diagnostic EP Catheter 05/10/2016
K171503 Innovative Health, LLC. Reprocessed CristaCath Diagnostic Electrophysiology Catheter 10/05/2017
K180710 Innovative Health, LLC. Reprocessed DecaNav Diagnostic Electrophysiology Catheter 06/19/2018
K171788 Innovative Health, LLC. Reprocessed Halo XP Diagnostic Electrophysiology Catheter 11/03/2017
K160421 Innovative Health, LLC. Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter 11/02/2016
K160496 Innovative Health, LLC. Reprocessed Inquiry Steerable Diagnostic EP Catheter 06/10/2016
K161393 Innovative Health, LLC. Reprocessed Orbiter ST Steerable Diagnostic EP Catheter 10/26/2016
K160303 Innovative Health, LLC. Reprocessed Polaris X Steerable Diagnostic EP Catheter 05/10/2016
K161827 INNOVATIVE HEALTH, LLC. Reprocessed Response Diagnostic Electrophysiology Catheters 12/08/2016
K162251 Innovative Health, LLC. Reprocessed Viking Diagnostic Electrophysiology Catheters 12/21/2016
K170922 Innovative Health, LLC. Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) 06/22/2017
K051220 STERILMED, INC. REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS 06/14/2005
K101789 STERILMED, INC. REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS 08/19/2010
K121158 STERILMED, INC. REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS 08/06/2012
K012523 STERILMED, INC. REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS 08/14/2002
K092158 STERILMED, INC. REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS 01/14/2010
K150357 STERILMED, INC. Reprocessed Electrophysiology Diagnostic Catheters 08/27/2015
K153006 STERILMED, INC. Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter 06/23/2016
K012678 STERILMED, INC. REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS 08/14/2002
K043513 STERILMED, INC. STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER 03/01/2005
K112292 STRYKER SUSTAINABILITY SOLUTIONS REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER 10/21/2011
K112232 STRYKER SUSTAINABILITY SOLUTIONS REPROCESSED ELECTROPHYSIOLOGY CATHETERS 09/26/2011
K161272 Surgical Instrument Service and Savings Inc Supreme and Response Electrophysiology Catheters 05/18/2017
K151617 SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN Livewire Electrophysiology Catheter 01/22/2016
K012687 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 08/01/2002
K012688 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 07/31/2002
K022316 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 10/10/2002
K023180 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 12/12/2002
K030114 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 03/21/2003
K040751 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 03/10/2005
K042074 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 03/09/2005
K050763 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 06/01/2005
K051043 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS 06/06/2005


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