The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Ventricular Access System.
| Device ID | K823790 |
| 510k Number | K823790 |
| Device Name: | VENTRICULAR ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
| Applicant | AMERICAN HEYER SCHULTE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-16 |
| Decision Date | 1983-04-28 |