The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath(r) Transesophageal Pacing Catheter.
| Device ID | K874154 |
| 510k Number | K874154 |
| Device Name: | ELECATH(R) TRANSESOPHAGEAL PACING CATHETER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Contact | Richard Ragula |
| Correspondent | Richard Ragula ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1988-04-29 |