cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more— 510(k) K233170
Substantially EquivalentAtriCure, Inc.
FDA 510(k) clearance K233170 for cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) +3 more, Substantially Equivalent on 2023-10-26. Applicant: AtriCure, Inc.. Device class: 2.
Clearance details
- Device name as filed
- cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
- Applicant
- AtriCure, Inc.
- Product code
- Product code GXH
- Device class
- Class 2
- Regulation
- 21 CFR 882.4250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mason, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.