K-number	K081049
Device name	FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
Applicant	Cryocath Technologies, Inc.
Product code	DRA
Device class	Class II
Decision date	Jun 27, 2008
Decision	Substantially Equivalent
Regulation	870.1280

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FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12

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