The following data is part of a premarket notification filed by Top Surgical Manufacturers Co. with the FDA for Top Venula I.v. Catheter Set.
| Device ID | K832624 |
| 510k Number | K832624 |
| Device Name: | TOP VENULA I.V. CATHETER SET |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TOP SURGICAL MANUFACTURERS 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 | 1983-08-04 |
| Decision Date | 1983-11-21 |