The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Vital-port Dual Lumen Vascular Access System 1121.
| Device ID | K912465 |
| 510k Number | K912465 |
| Device Name: | VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121 |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1991-07-30 |