Name: Predicase
Price: 199 USD

K-number	K071342
Device name	ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039
Applicant	Possis Medical, Inc.
Product code	QEZ
Device class	Class II
Decision date	Jul 31, 2007
Decision	Substantially Equivalent
Regulation	870.5150

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Source

View the full FDA submission: accessdata.fda.gov

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ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039

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