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510(k) Data Aggregation
(235 days)
The CoolCryo cryoapplicator is a single use, sterile device indicated for the cryosurgical treatment for ablation of arrhythmic cardiac tissue by freezing target tissues, inducing an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
The CoolCryo cryoapplicator can be used in adults and is intended for use in the clinical environment by trained healthcare professionals.
The CoolCryo control console is a nonsterile, reusable device which delivers cryogenic energy, namely liquid nitrogen, to the CoolCryo cyroapplicator. The CoolCryo control console can be used in adults and is intended for use in the clinical environment by trained healthcare professionals.
The CoolCryo is a sterile, single-use cryogsurgical device to freeze target tissue, blocking electrical conduction pathways by creating an inflammatory response or cyronecrosis.
The CoolCryo comprises a cryoapplicator and a control console with a liquid nitrogen reservoir:
- CC01-01 Cryoapplicator for cardiac cryoablation,
- CC01-21 Control console for cardiac cryoablation with liquid nitrogen reservoir.
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