The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Vital-port Vascular Access System 7010 And 7110.
Device ID | K912424 |
510k Number | K912424 |
Device Name: | VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110 |
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 | 1991-05-31 |
Decision Date | 1991-07-30 |