GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT

Occluder, Catheter Tip

ARTERIAL VASCULAR ENGINEERING, INC.

The following data is part of a premarket notification filed by Arterial Vascular Engineering, Inc. with the FDA for Gt1 Floppy, Gt1 Hi-per Flex, Gt1 Light Support.

Pre-market Notification Details

Device IDK983927
510k NumberK983927
Device Name:GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
ClassificationOccluder, Catheter Tip
Applicant ARTERIAL VASCULAR ENGINEERING, INC. 129 CONCORD RD. Billerica,  MA  01821
ContactDeborah L Herrington
CorrespondentDeborah L Herrington
ARTERIAL VASCULAR ENGINEERING, INC. 129 CONCORD RD. Billerica,  MA  01821
Product CodeDQT  
CFR Regulation Number870.1370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-05
Decision Date1999-03-11
Summary:summary

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