NLH — Catheter, Recording, Electrode, Reprocessed Class II
FDA product code NLH covers "Catheter, Recording, Electrode, Reprocessed", a Class II medical device regulated under 21 CFR 870.1220. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K233825 | innovative health | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | June 7, 2024 |
| K240972 | surgical instrument service and savings | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | 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 |