VYGON EXTENSION TUBES & CONNECTORS

Catheter, Intravascular, Diagnostic

EXCO, INC.

The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Vygon Extension Tubes & Connectors.

Pre-market Notification Details

Device IDK813140
510k NumberK813140
Device Name:VYGON EXTENSION TUBES & CONNECTORS
ClassificationCatheter, Intravascular, Diagnostic
Applicant EXCO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-05
Decision Date1981-11-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.