Name: Predicase
Price: 199 USD

K-number	K130639
Device name	ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
Applicant	Maquet Cardiopulmonary, AG
Product code	DWF
Device class	Class II
Decision date	May 16, 2013
Decision	Substantially Equivalent
Regulation	870.4210

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Source

View the full FDA submission: accessdata.fda.gov

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ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER

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