The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Balloon Pacing Catheter.
| Device ID | K843290 |
| 510k Number | K843290 |
| Device Name: | NUMED BALLOON PACING CATHETER |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Contact | Allen J Tower |
| Correspondent | Allen J Tower NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-21 |
| Decision Date | 1985-01-14 |