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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K220040
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
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Michael Liao
Correspondent
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Correspondent Contact Michael Liao
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received01/05/2022
Decision Date 07/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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