NLH
- Product code
- NLH
- Device name
- Catheter, Recording, Electrode, Reprocessed
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1220
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 70 (all years; only the last 3 years are listed here)
FDA classification 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).
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252405 | 2025-11-26 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed Boston Scientific Dynami… | |
| K250772 | 2025-07-11 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed Boston Scientific Dynami… | |
| K242225 | 2024-11-29 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed Abbott Inquiry Steerable… | |
| K241224 | 2024-11-15 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed Biosense Webster Webster… | |
| K240826 | 2024-10-11 | Sterilmed, Inc. | Reprocessed DECANAV Electrophysiology Catheter; Rep… | |
| K241156 | 2024-09-14 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed St. Jude Medical Respons… | |
| K233825 | 2024-06-07 | Innovative Health | Reprocessed Webster Duo-Decapolar Diagnostic EP Cath… | |
| K240972 | 2024-06-07 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed Medtronic Achieve Cathet… |
Official FDA classification page: NLH
Classification and pathway per current FDA publications. Data from openFDA (CC0).