Name: Predicase
Price: 199 USD

K-number	K200306
Device name	CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
Applicant	Abbott (Formerly Thoratec Corporation)
Product code	DWA
Device class	Class II
Decision date	Mar 6, 2020
Decision	Substantially Equivalent
Regulation	870.4380

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Source

View the full FDA submission: accessdata.fda.gov

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CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

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