The following data is part of a premarket notification filed by Roxwood Medical, Inc. with the FDA for Multicross Support Catheter.
| Device ID | K121763 |
| 510k Number | K121763 |
| Device Name: | MULTICROSS SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ROXWOOD MEDICAL, INC. 150 EXECUTIVE PARK BLVD, STE 3700 San Francisco, CA 94134 |
| Contact | Mehrdad Farhangnia |
| Correspondent | Mehrdad Farhangnia ROXWOOD MEDICAL, INC. 150 EXECUTIVE PARK BLVD, STE 3700 San Francisco, CA 94134 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2012-11-27 |
| Summary: | summary |