The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Vascular Access Port/cath Cat. #vp-xxx Vasport Ser.
Device ID | K873035 |
510k Number | K873035 |
Device Name: | VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER |
Classification | Catheter, Percutaneous |
Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
Contact | Jeanne Pierson |
Correspondent | Jeanne Pierson GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-04 |
Decision Date | 1987-09-25 |