CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm

Catheter, Percutaneous, Neurovasculature

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Cerebase Da Guide Sheath, 95cm, Cerebase Da Guide Sheath, 90cm, Cerebase Da Guide Sheath, 80cm, Cerebase Da Guide Sheath, 70cm.

Pre-market Notification Details

Device IDK192804
510k NumberK192804
Device Name:CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
ClassificationCatheter, Percutaneous, Neurovasculature
Applicant Medos International SARL Chemin-Blanc 38 Le Locle Neuchatel,  CH 2400
ContactMichael Liao
CorrespondentMichael Liao
Medos International SARL Chemin-Blanc 38 Le Locle Neuchatel,  CH 2400
Product CodeQJP  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-02-27

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