The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Vital-port Mini Vascular Access System.
Device ID | K931586 |
510k Number | K931586 |
Device Name: | VITAL-PORT MINI VASCULAR ACCESS SYSTEM |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
Contact | Fearnot, Phd |
Correspondent | Fearnot, Phd MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-31 |
Decision Date | 1993-09-27 |