Pentax of America, Inc.
C2 CryoBalloon Ablation System
SKU K212814UPC GEH
In Stock
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IIFDA 510(k) Cleared (K212814)
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Free shipping on orders over $99 · 30-day returns
Pentax of America, Inc.
Free shipping on orders over $99 · 30-day returns
C2 CryoBalloon Ablation System is an FDA 510(k)-cleared medical device (K212814) manufactured by Pentax of America, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2021. Regulation: 8.
