Name: Predicase
Price: 199 USD

K-number	K001565
Device name	STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
Applicant	Edwards Lifesciences, LLC
Product code	DWF
Device class	Class II
Decision date	Aug 10, 2000
Decision	Substantially Equivalent
Regulation	870.4210

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Source

View the full FDA submission: accessdata.fda.gov

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STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB

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