Cleared Traditional

POLARSHEATH? Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP? Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP? EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE? Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE? Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE? 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE? CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE? Pressure Sensor

K223824 · Boston Scientific Corporation · Cardiovascular

Mar 2023

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K223824 is an FDA 510(k) clearance for the POLARSHEATH? Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP? Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP? EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE? Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE? Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE? 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE? CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE? Pressure Sensor, a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Boston Scientific Corporation (St. Paul, US). The FDA issued a Cleared decision on March 22, 2023, 91 days after receiving the submission on December 21, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number	K223824 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2022
Decision Date	March 22, 2023
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF