Name: Predicase
Price: 199 USD

K-number	K090253
Device name	ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
Applicant	Possis Medical, Inc.
Product code	QEZ
Device class	Class II
Decision date	Apr 8, 2009
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 DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001

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