Catalogue number Bi-Directional Variable Radius Catheter, listed by St. Jude Medical Cardiovascular Division, 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 Reflexion Spiral™ | Listed by | St. Jude Medical Cardiovascular Division |
| FDA product code | DRF |
| Device type | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1220 |
| 510(k) | K072012 |
| Record published | 2016-01-28 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool dark, dry, place. Do not use if package is damaged. |
| Sizes | Catheter gauge 7 Fr |
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.