Biosense Webster, Inc.
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
SKU K231207UPC DQK
In Stock
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IIFDA 510(k) Cleared (K231207)
1
Free shipping on orders over $99 · 30-day returns
Biosense Webster, Inc.
Free shipping on orders over $99 · 30-day returns
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is an FDA 510(k)-cleared medical device (K231207) manufactured by Biosense Webster, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 6, 2023. Regulation: 8.
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