CIRCUL8 Connect DVT Prevention Device

Sleeve, Limb, Compressible

Ortho8, Inc.

The following data is part of a premarket notification filed by Ortho8, Inc. with the FDA for Circul8 Connect Dvt Prevention Device.

Pre-market Notification Details

Device IDK220761
510k NumberK220761
Device Name:CIRCUL8 Connect DVT Prevention Device
ClassificationSleeve, Limb, Compressible
Applicant Ortho8, Inc. 2217 Plaza Drive Rocklin,  CA  95765
ContactJeff Culhane
CorrespondentJohn Beasley
MedTech Review, LLC 257 Garnet Garden Street Henderson,  NV  89015
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-15
Decision Date2022-06-03

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