The following data is part of a premarket notification filed by Harmac Medical Products, Inc. with the FDA for Harmac Bipolar Temporary Pacing Catheter With Stylet.
| Device ID | K963073 |
| 510k Number | K963073 |
| Device Name: | HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. Buffalo, NY 14211 -1797 |
| Contact | Joseph M Konieczny |
| Correspondent | Joseph M Konieczny HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. Buffalo, NY 14211 -1797 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1997-08-14 |