Name: Predicase
Price: 199 USD

K-number	K000379
Device name	MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
Applicant	Medtronic Vascular
Product code	DTM
Device class	Class II
Decision date	Feb 16, 2000
Decision	Substantially Equivalent
Regulation	870.4260

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Source

View the full FDA submission: accessdata.fda.gov

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MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352

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