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C2 CryoBalloon Ablation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212814
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/29/2021
Days to Decision
87 days
Submission Type
Summary

C2 CryoBalloon Ablation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212814
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/29/2021
Days to Decision
87 days
Submission Type
Summary