The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Open Tip Bipolar Pacing Catheter.
| Device ID | K850324 |
| 510k Number | K850324 |
| Device Name: | ELECATH OPEN TIP BIPOLAR PACING CATHETER |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Contact | Silpe |
| Correspondent | Silpe ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-03-27 |