CoraCross
Catheter, Percutaneous
Reflow Medical
The following data is part of a premarket notification filed by Reflow Medical with the FDA for Coracross.
Pre-market Notification Details
| Device ID | K210188 |
| 510k Number | K210188 |
| Device Name: | CoraCross |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-05-28 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850025525053 | K210188 | 000 |
| 00850025525046 | K210188 | 000 |
Trademark Results [CoraCross]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORACROSS 98187387 not registered Live/Pending |
ReFlow Medical, Inc. 2023-09-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.