HEARTPORT MAZE SYSTEM: CRYOPROBE SET

Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

HEARTPORT, INC.

The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Maze System: Cryoprobe Set.

Pre-market Notification Details

Device IDK970496
510k NumberK970496
Device Name:HEARTPORT MAZE SYSTEM: CRYOPROBE SET
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City,  CA  94063
ContactMarianne C Drennan
CorrespondentMarianne C Drennan
HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City,  CA  94063
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-10
Decision Date1997-05-09
Summary:summary

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