FDA 510(k) Applications Submitted by Derek Charchuk

FDA 510(k) Number Submission Date Device Name Applicant
K223824 12/21/2022 POLARSHEATHÖ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAPÖ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAPÖ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZEÖ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZEÖ Esophageal Temperature S Boston Scientific Corporation


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