Name: Predicase
Price: 199 USD

K-number	K083784
Device name	PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
Applicant	Vascular Solutions, Inc.
Product code	QEZ
Device class	Class II
Decision date	Mar 30, 2009
Decision	Substantially Equivalent
Regulation	870.5150

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Source

View the full FDA submission: accessdata.fda.gov

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PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,

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