HEMASITE GRAFTLESS VASCULAR ACESS

Cannula, A-v Shunt

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Hemasite Graftless Vascular Acess.

Pre-market Notification Details

Device IDK812890
510k NumberK812890
Device Name:HEMASITE GRAFTLESS VASCULAR ACESS
ClassificationCannula, A-v Shunt
Applicant RENAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFIQ  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-15
Decision Date1981-11-16

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