Name: Predicase
Price: 199 USD

K-number	K223824
Device name	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
Applicant	Boston Scientific Corporation
Product code	DRA
Device class	Class II
Decision date	Mar 22, 2023
Decision	Substantially Equivalent
Regulation	870.1280

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Source

View the full FDA submission: accessdata.fda.gov

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