The following data is part of a premarket notification filed by Medi-dyne, Inc. with the FDA for Medi-dyne Guiding Catheter.
| Device ID | K970401 |
| 510k Number | K970401 |
| Device Name: | MEDI-DYNE GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MEDI-DYNE, INC. 604 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Norma Hall |
| Correspondent | Norma Hall MEDI-DYNE, INC. 604 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-08-01 |
| Summary: | summary |