The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Maze System: Cryoprobe Set.
| Device ID | K970496 |
| 510k Number | K970496 |
| Device Name: | HEARTPORT MAZE SYSTEM: CRYOPROBE SET |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Marianne C Drennan |
| Correspondent | Marianne C Drennan HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-05-09 |
| Summary: | summary |