The following data is part of a premarket notification filed by Reflow Medical with the FDA for Spex Support Catheter.
| Device ID | K193012 |
| 510k Number | K193012 |
| Device Name: | SpeX Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | ReFlow Medical 208 Avenida Fabricante #100 San Clemente, CA 92672 |
| Contact | Krystal Santiago |
| Correspondent | Krystal Santiago ReFlow Medical 208 Avenida Fabricante #100 San Clemente, CA 92672 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-29 |
| Decision Date | 2020-02-19 |