cryoICE cryoXT cryoablation probe (cryoXT)— 510(k) K250371
Substantially EquivalentAtriCure, Inc.
FDA 510(k) clearance K250371 for cryoICE cryoXT cryoablation probe (cryoXT), Substantially Equivalent on 2025-04-10. Applicant: AtriCure, Inc.. Device class: 2.
Clearance details
- 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
- Traditional
- Location
- Mason, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.