The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Pacewedge Dual Press. Bipolar.
| Device ID | K832850 |
| 510k Number | K832850 |
| Device Name: | ELECATH PACEWEDGE DUAL PRESS. BIPOLAR |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | ELECTRO-CATHETER CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-22 |
| Decision Date | 1983-10-19 |