Name: Predicase
Price: 199 USD

K-number	K933713
Device name	VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
Applicant	Baxter Healthcare Corp
Product code	DTN
Device class	Class II
Decision date	Mar 1, 1994
Decision	Substantially Equivalent
Regulation	870.4400

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Source

View the full FDA submission: accessdata.fda.gov

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VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT

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