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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K213264

CARTO 3 EP Navigation System Version 7.2 · Biosense Webster, Inc. · decided 2021-10-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CARTO 3FG540000BIOSENSE WEBSTER (ISRAEL) LTD.DQK10846835000870