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 |
| K233825 | Innovative Health | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | 06/07/2024 |
| 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 |
| K240826 | Sterilmed, Inc. | Reprocessed DECANAVÖ Electrophysiology Catheter; Reprocessed WEBSTER« Duo-Decapolar Electrophysiology Catheter | 10/11/2024 |
| 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 |
| K242225 | Surgical Instrument Service and Savings Inc. | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | 11/29/2024 |
| K250772 | Surgical Instrument Service and Savings Inc. | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | 07/11/2025 |
| K240972 | Surgical Instrument Service and Savings Inc. | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | 06/07/2024 |
| K221067 | Surgical Instrument Service and Savings Inc. | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter | 05/31/2023 |
| K241156 | Surgical Instrument Service and Savings Inc. | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, | 09/14/2024 |
| K241224 | Surgical Instrument Service and Savings Inc.(dba Medline ReN | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD7 | 11/15/2024 |
| 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
