The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Intracath Intravenous Catheter Unit.
| Device ID | K833135 |
| 510k Number | K833135 |
| Device Name: | INTRACATH INTRAVENOUS CATHETER UNIT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | PARKE-DAVIS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-14 |
| Decision Date | 1983-11-21 |