The following data is part of a premarket notification filed by Therox, Inc. with the FDA for Therox Infusion Catheter, Model Inca-1.
| Device ID | K052637 |
| 510k Number | K052637 |
| Device Name: | THEROX INFUSION CATHETER, MODEL INCA-1 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | THEROX, INC. 2400 MICHELSON DR. Irvine, CA 92612 -1310 |
| Contact | David W Mullis Jr. |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2006-03-08 |
| Summary: | summary |