NLH · Catheter, Recording, Electrode, Reprocessed
Cardiovascular · 21 CFR 870.1220 · Class 2
Overview
| Product Code | NLH |
|---|---|
| Device Name | Catheter, Recording, Electrode, Reprocessed |
| Regulation | 21 CFR 870.1220 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 70)
Showing 20 most recent of 70 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | Nov 26, 2025 | SESE |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | Jul 11, 2025 | SESE |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | Nov 29, 2024 | SESE |
| 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 | Nov 15, 2024 | SESE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | Sterilmed, Inc. | Oct 11, 2024 | SESE |
| 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. | Sep 14, 2024 | SESE |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | Surgical Instrument Service and Savings, Inc. | Jun 7, 2024 | SESE |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health | Jun 7, 2024 | SESE |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter | Surgical Instrument Service and Savings, Inc. | May 31, 2023 | SESE |
| K221854 | Reprocesses Umbilical Cable | Innovative Health, LLC | Aug 6, 2022 | SESE |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | Innovative Health, LLC | Sep 15, 2021 | SESE |
| K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | Innovative Health, LLC | May 4, 2021 | SESE |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | Stryker Sustainability Solutions | May 13, 2020 | SESE |
| K193263 | Reprocessed Achieve Catheter Connecting Cable | Innovative Health, LLC | Jan 24, 2020 | SESE |
| K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter | Innovative Health, LLC | Oct 30, 2019 | SESE |
| K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | Innovative Health, LLC | Aug 23, 2019 | SESE |
| K182488 | Reprocessed Response Diagnostic Electrophysiology Catheter | Innovative Health, LLC | Feb 22, 2019 | SESE |
| K181056 | Reprocessed CS Diagnostic Electrophysiology Catheter | Stryker Sustainability Solutions | Jan 24, 2019 | SESE |
| K181897 | Reprocessed Marinr Diagnostic EP Catheter | Innovative Health, LLC | Nov 15, 2018 | SESE |
| K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | Innovative Health, LLC | Oct 27, 2018 | SESE |
Top Applicants
- Innovative Health, LLC — 23 clearances
- Sterilmed, Inc. — 10 clearances
- Alliance Medical Corp. — 9 clearances
- Vanguard Medical Concepts, Inc. — 9 clearances
- Surgical Instrument Service and Savings, Inc. — 7 clearances
