The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Multi-purpose Arterial Surger.
| Device ID | K790444 |
| 510k Number | K790444 |
| Device Name: | ELECATH MULTI-PURPOSE ARTERIAL SURGER |
| Classification | Catheter, Balloon Type |
| Applicant | ELECTRO-CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBA |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-06 |
| Decision Date | 1979-06-11 |