The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Central Venous Access Catheter Cvac-xx.
| Device ID | K841587 |
| 510k Number | K841587 |
| Device Name: | CENTRAL VENOUS ACCESS CATHETER CVAC-XX |
| Classification | Catheter, Percutaneous |
| Applicant | GISH BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-27 |
| Decision Date | 1984-06-13 |