The following data is part of a premarket notification filed by Ivera Medical, Inc. with the FDA for Curos Red Port Protector.
| Device ID | K140657 |
| 510k Number | K140657 |
| Device Name: | CUROS RED PORT PROTECTOR |
| Classification | Cap, Device Disinfectant |
| Applicant | IVERA MEDICAL, INC. 2731 LOKER AVENUE WEST Carlsbad, CA 92010 |
| Contact | Don Canal |
| Correspondent | Don Canal IVERA MEDICAL, INC. 2731 LOKER AVENUE WEST Carlsbad, CA 92010 |
| Product Code | QBP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-14 |
| Decision Date | 2014-12-04 |
| Summary: | summary |