The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Portal Vein/biliary Drain Assm.
| Device ID | K821488 |
| 510k Number | K821488 |
| Device Name: | ELECATH PORTAL VEIN/BILIARY DRAIN ASSM |
| Classification | Components, Wheelchair |
| Applicant | ELECTRO-CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNN |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-18 |
| Decision Date | 1982-05-28 |