The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Chemotherapy Infusion Catheter.
Device ID | K822096 |
510k Number | K822096 |
Device Name: | CHEMOTHERAPY INFUSION CATHETER |
Classification | Catheter, Infusion |
Applicant | AMERICAN HEYER SCHULTE 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JCY |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-16 |
Decision Date | 1983-04-12 |