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 |
| K193263 | Innovative Health, LLC. | Reprocessed Achieve Catheter Connecting Cable | 01/24/2020 |
| K181458 | Innovative Health, LLC. | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | 10/27/2018 |
| K171503 | Innovative Health, LLC. | Reprocessed CristaCath Diagnostic Electrophysiology Catheter | 10/05/2017 |
| K180710 | Innovative Health, LLC. | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | 06/19/2018 |
| K211276 | Innovative Health, LLC. | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | 09/15/2021 |
| 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 |
| K190127 | Innovative Health, LLC. | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | 08/23/2019 |
| K181897 | Innovative Health, LLC. | Reprocessed Marinr Diagnostic EP Catheter | 11/15/2018 |
| 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 |
| K191170 | Innovative Health, LLC. | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter | 10/30/2019 |
| K182488 | Innovative Health, LLC. | Reprocessed Response Diagnostic Electrophysiology Catheter | 02/22/2019 |
| K161827 | INNOVATIVE HEALTH, LLC. | Reprocessed Response Diagnostic Electrophysiology Catheters | 12/08/2016 |
| K181618 | Innovative Health, LLC. | Reprocessed Torqr Diagnostic EP Catheter | 10/18/2018 |
| 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 |
| K203655 | Innovative Health, LLC. | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | 05/04/2021 |
| K221854 | Innovative Health, LLC. | Reprocesses Umbilical Cable | 08/06/2022 |
| K051220 | STERILMED, INC. | REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | 06/14/2005 |
| K101789 | STERILMED, INC. | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | 08/19/2010 |
| K012523 | STERILMED, INC. | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | 08/14/2002 |
| K092158 | STERILMED, INC. | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | 01/14/2010 |
| K121158 | STERILMED, INC. | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | 08/06/2012 |
| 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 |
| K200205 | Stryker Sustainability Solutions | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | 05/13/2020 |
| K181056 | Stryker Sustainability Solutions | Reprocessed CS Diagnostic Electrophysiology Catheter | 01/24/2019 |
| 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 |
| K221067 | Surgical Instrument Service and Savings Inc. | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter | 05/31/2023 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
