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 |