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AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200697
510(k) Type
Traditional
Applicant
AtriCure Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/2020
Days to Decision
281 days
Submission Type
Summary

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200697
510(k) Type
Traditional
Applicant
AtriCure Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/2020
Days to Decision
281 days
Submission Type
Summary