The following data is part of a premarket notification filed by Reflow Medical, Inc. with the FDA for Spex Support Catheter.
| Device ID | K173662 |
| 510k Number | K173662 |
| Device Name: | SpeX Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | ReFlow Medical, Inc. 1003 Calle Sombra San Clemente, CA 92673 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine ReFlow Medical, Inc. 1003 Calle Sombra San Clemente, CA 92673 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-29 |
| Decision Date | 2017-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856492005371 | K173662 | 000 |
| 00850025525077 | K173662 | 000 |
| 00850025525084 | K173662 | 000 |
| 00850025525091 | K173662 | 000 |
| 00856492005326 | K173662 | 000 |
| 00856492005333 | K173662 | 000 |
| 00856492005340 | K173662 | 000 |
| 00856492005357 | K173662 | 000 |
| 00856492005364 | K173662 | 000 |
| 00850025525060 | K173662 | 000 |