The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Central Venous Access Catheter Cvac.
| Device ID | K832396 |
| 510k Number | K832396 |
| Device Name: | CENTRAL VENOUS ACCESS CATHETER CVAC |
| Classification | Radioimmunoassay, Digoxin (3-h), Goat Antibody, 2nd Antibody Sep. |
| Applicant | GISH BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DOY |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-20 |
| Decision Date | 1983-08-31 |