The following data is part of a premarket notification filed by Translational Research Institute with the FDA for Nd Nabil Dib Infusion Catheter.
| Device ID | K130569 |
| 510k Number | K130569 |
| Device Name: | ND NABIL DIB INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | Translational Research Institute 3420 S MERCY RD #312 Gilbert, AZ 85297 |
| Contact | Deann Dana |
| Correspondent | Deann Dana Translational Research Institute 3420 S MERCY RD #312 Gilbert, AZ 85297 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-04 |
| Decision Date | 2013-11-15 |
| Summary: | summary |