The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Heparin Coated Thermal Dilution.
| Device ID | K832787 |
| 510k Number | K832787 |
| Device Name: | ELECATH HEPARIN COATED THERMAL DILUTION |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | ELECTRO-CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-16 |
| Decision Date | 1983-10-04 |