K-number	K070357
Device name	FLEXCATH STEERABLE SHEATH & DILATOR
Applicant	Cryocath Technologies, Inc.
Product code	DRA
Device class	Class II
Decision date	Dec 28, 2007
Decision	Substantially Equivalent
Regulation	870.1280

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View the full FDA submission: accessdata.fda.gov

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FLEXCATH STEERABLE SHEATH & DILATOR

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