The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Vital-port Vasc Access Sys W/dual Lum Injectrol Ca.
Device ID | K932411 |
510k Number | K932411 |
Device Name: | VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA |
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 | 1993-05-18 |
Decision Date | 1994-09-19 |