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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K180248

VascuEase IC-1200-WH · Bio Compression Systems, Inc. · decided 2018-08-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
VascuEase Replacement Sleeve, LeftGID-1000-LBio Compression Systems, IncJOW00812311023049
VascuEaseIC-1200-WHBio Compression Systems, IncJOW00812311022011
VascuEase Replacement Sleeve, RightGID-1000-RBio Compression Systems, IncJOW00812311023063
VascuEase Replacement SleevesGID-1000-PRBio Compression Systems, IncJOW00812311023056