Catalogue number 353177, listed by Biotronik SE & Co. KG, Germany, under Catheter, Electrode Recording, Or Probe, Electrode Recording. 5 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (2), Tianjin (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for MPK-4-R/2,0m | Listed by | Biotronik SE & Co. KG, Germany |
| FDA product code | DRF |
| Device type | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1220 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K201445 |
| Record published | 2021-10-22 |
| Record revised | 2022-08-25 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 75 °F; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 75 % RH |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.