CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, And Freeform XtraSoft Detachable Coil Systems

Device, Neurovascular Embolization

Medos International, SARL

The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Cerepak Uniform, Uniform Xl, Uniform 3d, Heliform Soft, Heliform Xtrasoft, Heliform Xl, Heliform Xtrasoft Xl, Freeform, Freeform Mini, And Freeform Xtrasoft Detachable Coil Systems.

Pre-market Notification Details

Device IDK220040
510k NumberK220040
Device Name:CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, And Freeform XtraSoft Detachable Coil Systems
ClassificationDevice, Neurovascular Embolization
Applicant Medos International, SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactMichael Liao
CorrespondentMichael Liao
Medos International, SARL Chemin-Blanc 38 Le Locle,  CH 2400
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-05
Decision Date2022-07-14

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.