The following data is part of a premarket notification filed by Roxwood Medical, Inc. with the FDA for Centercross Catheter.
| Device ID | K140910 |
| 510k Number | K140910 |
| Device Name: | CENTERCROSS CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ROXWOOD MEDICAL, INC. 400 SEAPORT CT, SUITE #103 Redwood City, CA 94063 |
| Contact | Mehrdad Farhangnia |
| Correspondent | Mehrdad Farhangnia 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 | 2014-04-09 |
| Decision Date | 2014-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858480007077 | K140910 | 000 |