The following data is part of a premarket notification filed by Roxwood Medical, Inc. with the FDA for Centercross Ultra Catheter.
| Device ID | K152456 |
| 510k Number | K152456 |
| Device Name: | CenterCross Ultra Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | ROXWOOD MEDICAL, INC. 400 SEAPORT CT, SUITE #103 Redwood City, CA 94063 |
| Contact | Grace Li |
| Correspondent | Grace Li ROXWOOD MEDICAL, INC. 400 SEAPORT CT, SUITE #103 Redwood City, CA 94063 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-28 |
| Decision Date | 2016-01-26 |
| Summary: | summary |