The following data is part of a premarket notification filed by Roxwood Medical, Inc. with the FDA for Microcross Catheter.
| Device ID | K143744 |
| 510k Number | K143744 |
| Device Name: | MicroCross 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 | 2014-12-31 |
| Decision Date | 2015-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858480007169 | K143744 | 000 |
| 00858480007152 | K143744 | 000 |
| 00858480007145 | K143744 | 000 |
| 00858480007138 | K143744 | 000 |
| 00858480007114 | K143744 | 000 |
| 00858480007107 | K143744 | 000 |