The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Vasport Vascular Access Port.
| Device ID | K953571 |
| 510k Number | K953571 |
| Device Name: | VASPORT VASCULAR ACCESS PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Contact | Debra J Kridner |
| Correspondent | Debra J Kridner GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1995-10-02 |