Wiygul Catheter

Catheter, Straight

Big Blue Biotech, Inc.

The following data is part of a premarket notification filed by Big Blue Biotech, Inc. with the FDA for Wiygul Catheter.

Pre-market Notification Details

Device IDK202566
510k NumberK202566
Device Name:Wiygul Catheter
ClassificationCatheter, Straight
Applicant Big Blue Biotech, Inc. 690 Canton Street, Suite 302 Westwood,  MA  02090
ContactRuss Olsen
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-09-04
Decision Date2020-09-30

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