Name: Predicase
Price: 199 USD

K-number	K102725
Device name	CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
Applicant	Bridge Medical, Inc.
Product code	DQY
Device class	Class II
Decision date	May 10, 2011
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M

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