The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Metronic Model F7700 Heart Valve Sizers.
| Device ID | K852612 |
| 510k Number | K852612 |
| Device Name: | METRONIC MODEL F7700 HEART VALVE SIZERS |
| Classification | Sizer, Heart-valve, Prosthesis |
| Applicant | MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Contact | Pam Sinnott |
| Correspondent | Pam Sinnott MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Product Code | DTI |
| CFR Regulation Number | 870.3945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-19 |
| Decision Date | 1985-09-23 |