The following data is part of a premarket notification filed by Reflow Medical with the FDA for Spex Lp Support Catheter.
| Device ID | K200094 |
| 510k Number | K200094 |
| Device Name: | SpeX LP 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-16 |
| Decision Date | 2020-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856492005685 | K200094 | 000 |
| 00856492005678 | K200094 | 000 |
| 00856492005661 | K200094 | 000 |
| 00856492005654 | K200094 | 000 |
| 00856492005647 | K200094 | 000 |
| 00856492005630 | K200094 | 000 |
| 10850025525036 | K200094 | 000 |
| 10850025525029 | K200094 | 000 |
| 00850025525015 | K200094 | 000 |