VENTRICULAR ACCESS SYSTEM

Port & Catheter, Implanted, Subcutaneous, Intraventricular

AMERICAN HEYER SCHULTE

The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Ventricular Access System.

Pre-market Notification Details

Device IDK823790
510k NumberK823790
Device Name:VENTRICULAR ACCESS SYSTEM
ClassificationPort & Catheter, Implanted, Subcutaneous, Intraventricular
Applicant AMERICAN HEYER SCHULTE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLKG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-16
Decision Date1983-04-28

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