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 |