Name: Predicase
Price: 199 USD

K-number	K062531
Device name	ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
Applicant	Cordis Corp., A Johnson & Johnson Co.
Product code	NTE
Device class	Class II
Decision date	Sep 22, 2006
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

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