The following data is part of a premarket notification filed by Reflow Medical, Inc. with the FDA for Coraforce And Coraflex Support Catheters.
| Device ID | K201811 |
| 510k Number | K201811 |
| Device Name: | CoraForce And CoraFlex Support Catheters |
| Classification | Catheter, Percutaneous |
| Applicant | Reflow Medical, Inc. 208 Avenida Fabricante #100 San Clemente, CA 92672 |
| Contact | Krystal Santiago |
| Correspondent | Krystal Santiago Reflow Medical, Inc. 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 | 2020-07-01 |
| Decision Date | 2020-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856492005722 | K201811 | 000 |
| 00856492005715 | K201811 | 000 |
| 00856492005708 | K201811 | 000 |
| 00856492005692 | K201811 | 000 |