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 |