K-number	K920157
Device name	SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
Applicant	Schneider Intl., Ltd.
Product code	DXY
Device class	Class III
Decision date	Mar 16, 1992
Decision	Substantially Equivalent
Regulation	870.3610

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View the full FDA submission: accessdata.fda.gov

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SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER

Everything you need for a 510(k) submission. Nothing you don't.