The following data is part of a premarket notification filed by Therox, Inc. with the FDA for Therox Infusion Guidewires.
| Device ID | K971719 |
| 510k Number | K971719 |
| Device Name: | THEROX INFUSION GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | THEROX, INC. 2025 NEWPORT BLVD SUITE 200 Costa Mesa, CA 92627 |
| Contact | Paul J Zalesky |
| Correspondent | Paul J Zalesky THEROX, INC. 2025 NEWPORT BLVD SUITE 200 Costa Mesa, CA 92627 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-11-03 |
| Summary: | summary |