FDA 510(k) clearance · back to tracker

AtriCure cryoICE cryo-ablation probe (CRYO2)

AtriCure, Inc. cleared K180138 on 2018-02-15, decision: substantially equivalent

K-number

K180138

Sponsor

AtriCure, Inc.

Device

AtriCure cryoICE cryo-ablation probe (CRYO2)

Class

Class II

Decision

Substantially Equivalent

Decision date

2018-02-15

Product code

GXH

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.4250

Official FDA record

Open K180138on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.