NLH — Catheter, Recording, Electrode, Reprocessed Class II
Classification Details
- Product Code
- NLH
- Device Class
- Class II
- Regulation Number
- 870.1220
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252405 | surgical instrument service and savings | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerab | November 26, 2025 |
| K250772 | surgical instrument service and savings | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerabl | July 11, 2025 |
| K242225 | surgical instrument service and savings | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | November 29, 2024 |
| K241224 | surgical instrument service and savings inc.(dba medline ren | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer T | November 15, 2024 |
| K240826 | sterilmed | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapo | October 11, 2024 |
| K241156 | surgical instrument service and savings | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter | September 14, 2024 |
| K240972 | surgical instrument service and savings | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | June 7, 2024 |
| K233825 | innovative health | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | June 7, 2024 |
| K221067 | surgical instrument service and savings | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiolog | May 31, 2023 |
| K221854 | innovative health | Reprocesses Umbilical Cable | August 6, 2022 |
| K211276 | innovative health | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters | September 15, 2021 |
| K203655 | innovative health | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webste | May 4, 2021 |
| K200205 | stryker sustainability solutions | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled | May 13, 2020 |
| K193263 | innovative health | Reprocessed Achieve Catheter Connecting Cable | January 24, 2020 |
| K191170 | innovative health | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Ca | October 30, 2019 |
| K190127 | innovative health | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter | August 23, 2019 |
| K182488 | innovative health | Reprocessed Response Diagnostic Electrophysiology Catheter | February 22, 2019 |
| K181056 | stryker sustainability solutions | Reprocessed CS Diagnostic Electrophysiology Catheter | January 24, 2019 |
| K181897 | innovative health | Reprocessed Marinr Diagnostic EP Catheter | November 15, 2018 |
| K181458 | innovative health | Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter | October 27, 2018 |