The following data is part of a premarket notification filed by Zeon Medical Corp. with the FDA for Xemex Temporary Pacing Catheter A Modified.
| Device ID | K913521 |
| 510k Number | K913521 |
| Device Name: | XEMEX TEMPORARY PACING CATHETER A MODIFIED |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | ZEON MEDICAL CORP. 50 MAIN ST. White Plains, NY 10606 |
| Contact | Robert Burns |
| Correspondent | Robert Burns 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 | 1991-08-06 |
| Decision Date | 1991-12-27 |