FDA Product Code
FDA Product Code NLH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1220
510(k) Clearances — 70 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | 2025-11-26 | Traditional | PDF ↗ |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | 2024-11-29 | Traditional | PDF ↗ |
| K241224 | 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, BD710FJ282CT) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2024-11-15 | Traditional | PDF ↗ |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | Sterilmed, Inc. | 2024-10-11 | Traditional | PDF ↗ |
| K241156 | 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, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 | Surgical Instrument Service and Savings, Inc. | 2024-09-14 | Traditional | PDF ↗ |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | Surgical Instrument Service and Savings, Inc. | 2024-06-07 | Traditional | PDF ↗ |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health | 2024-06-07 | Traditional | PDF ↗ |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter | Surgical Instrument Service and Savings, Inc. | 2023-05-31 | Traditional | PDF ↗ |
| K221854 | Reprocesses Umbilical Cable | Innovative Health, LLC | 2022-08-06 | Traditional | PDF ↗ |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2021-09-15 | Traditional | PDF ↗ |
| K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | Innovative Health, LLC | 2021-05-04 | Traditional | PDF ↗ |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | Stryker Sustainability Solutions | 2020-05-13 | Traditional | PDF ↗ |
| K193263 | Reprocessed Achieve Catheter Connecting Cable | Innovative Health, LLC | 2020-01-24 | Traditional | PDF ↗ |
| K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter | Innovative Health, LLC | 2019-10-30 | Traditional | PDF ↗ |
| K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019-08-23 | Traditional | PDF ↗ |
| K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019-02-22 | Traditional | PDF ↗ |
| K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter | Stryker Sustainability Solutions | 2019-01-24 | Traditional | PDF ↗ |
| K181897 | Reprocessed Marinr Diagnostic EP Catheter | Innovative Health, LLC | 2018-11-15 | Traditional | PDF ↗ |
| K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | Innovative Health, LLC | 2018-10-27 | Traditional | PDF ↗ |
| K181618 | Reprocessed Torqr Diagnostic EP Catheter | Innovative Health, LLC | 2018-10-18 | Traditional | PDF ↗ |
| K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2018-06-19 | Traditional | PDF ↗ |
| K171788 | Reprocessed Halo XP Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2017-11-03 | Traditional | PDF ↗ |
| K171503 | Reprocessed CristaCath Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2017-10-05 | Traditional | PDF ↗ |
| K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | Innovative Health, LLC | 2017-06-22 | Traditional | PDF ↗ |
| K161272 | Supreme and Response Electrophysiology Catheters | Surgical Instrument Service and Savings, Inc. | 2017-05-18 | Traditional | PDF ↗ |
| K162251 | Reprocessed Viking Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2016-12-21 | Traditional | PDF ↗ |
| K161827 | Reprocessed Response Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2016-12-08 | Traditional | PDF ↗ |
| K160421 | Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2016-11-02 | Traditional | PDF ↗ |
| K161393 | Reprocessed Orbiter ST Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2016-10-26 | Traditional | PDF ↗ |
| K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | 2016-09-30 | Traditional | PDF ↗ |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | Sterilmed, Inc. | 2016-06-23 | Traditional | PDF ↗ |
| K160496 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2016-06-10 | Traditional | PDF ↗ |
| K160303 | Reprocessed Polaris X Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2016-05-10 | Traditional | PDF ↗ |
| K160242 | Reprocessed Livewire Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2016-05-10 | Traditional | PDF ↗ |
| K153153 | Reprocessed Electrophysiology Catheter | Innovative Health, LLC | 2016-03-14 | Traditional | PDF ↗ |
| K151617 | Livewire Electrophysiology Catheter | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016-01-22 | Traditional | PDF ↗ |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | Sterilmed, Inc. | 2015-08-27 | Traditional | PDF ↗ |
| K121158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | Sterilmed, Inc. | 2012-08-06 | Traditional | PDF ↗ |
| K112292 | REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | 2011-10-21 | Traditional | PDF ↗ |
| K112232 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Stryker Sustainability Solutions | 2011-09-26 | Traditional | PDF ↗ |
| K101789 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | Sterilmed, Inc. | 2010-08-19 | Traditional | PDF ↗ |
| K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | Ascent Healthcare Solutions | 2010-05-28 | Traditional | PDF ↗ |
| K092158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | Sterilmed, Inc. | 2010-01-14 | Traditional | PDF ↗ |
| K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Ascent Healthcare Solutions | 2009-04-01 | Traditional | PDF ↗ |
| K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Ascent Healthcare Solutions | 2008-09-16 | Traditional | PDF ↗ |
| K081329 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Ascent Healthcare Solutions | 2008-07-09 | Traditional | PDF ↗ |
| K061045 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Alliance Medical Corp. | 2006-08-31 | Traditional | PDF ↗ |
| K052603 | REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS | Alliance Medical Corp. | 2005-11-16 | Traditional | PDF ↗ |
| K052414 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Alliance Medical Corp. | 2005-11-16 | Traditional | PDF ↗ |
| K051220 | REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | Sterilmed, Inc. | 2005-06-14 | Traditional | PDF ↗ |
| K051043 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2005-06-06 | Traditional | PDF ↗ |
| K050763 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2005-06-01 | Traditional | PDF ↗ |
| K043392 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Alliance Medical Corp. | 2005-03-25 | Traditional | PDF ↗ |
| K043393 | REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS | Alliance Medical Corp. | 2005-03-23 | Traditional | PDF ↗ |
| K040751 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2005-03-10 | Traditional | PDF ↗ |
| K042074 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2005-03-09 | Traditional | PDF ↗ |
| K043513 | STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER | Sterilmed, Inc. | 2005-03-01 | Traditional | PDF ↗ |
| K030279 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Alliance Medical Corp. | 2003-10-03 | Traditional | PDF ↗ |
| K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Alliance Medical, Inc. | 2003-09-24 | Traditional | PDF ↗ |
| K030109 | ELECTROPHYSIOLOGY CATHETER | Alliance Medical Corp. | 2003-08-08 | Traditional | PDF ↗ |
| K030026 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Alliance Medical Corp. | 2003-05-02 | Traditional | PDF ↗ |
| K030114 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2003-03-21 | Traditional | PDF ↗ |
| K023180 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2002-12-12 | Traditional | PDF ↗ |
| K022316 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2002-10-10 | Traditional | PDF ↗ |
| K012523 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | Sterilmed, Inc. | 2002-08-14 | Traditional | PDF ↗ |
| K012678 | REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | Sterilmed, Inc. | 2002-08-14 | Traditional | PDF ↗ |
| K012708 | ELECTROPHYSIOLOGY CATHETER | Alliance Medical Corp. | 2002-08-13 | Traditional | PDF ↗ |
| K012687 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2002-08-01 | Traditional | PDF ↗ |
| K012688 | VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS | Vanguard Medical Concepts, Inc. | 2002-07-31 | Traditional | PDF ↗ |
Product code NLH · Class II · Cardiovascular. Data: openFDA.