Last synced on 14 June 2024 at 11:05 pm

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233170
510(k) Type
Special
Applicant
AtriCure, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/26/2023
Days to Decision
29 days
Submission Type
Summary

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233170
510(k) Type
Special
Applicant
AtriCure, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/26/2023
Days to Decision
29 days
Submission Type
Summary