The following data is part of a premarket notification filed by Zeon Medical Corp. with the FDA for Xemex Temporary Pacing Catheter A.
| Device ID | K904868 |
| 510k Number | K904868 |
| Device Name: | XEMEX TEMPORARY PACING CATHETER A |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | ZEON MEDICAL CORP. 50 MAIN ST. White Plains, NY 10606 |
| Contact | Burns, Jr. |
| Correspondent | Burns, Jr. ZEON MEDICAL CORP. 50 MAIN ST. White Plains, NY 10606 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-29 |
| Decision Date | 1991-05-16 |