The following data is part of a premarket notification filed by Harmac Medical Products, Inc. with the FDA for Harmac Balloon Angiographic Catheter.
| Device ID | K962829 |
| 510k Number | K962829 |
| Device Name: | HARMAC BALLOON ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. Buffalo, NY 14211 -1797 |
| Contact | Joseph M Knoieczny |
| Correspondent | Joseph M Knoieczny HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. Buffalo, NY 14211 -1797 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1997-10-16 |