SafeBreak Vascular

Intravenous Catheter Force-activated Separation Device.

Site Saver, Inc. D/b/a Lineus Medical

The following data is part of a De Novo classification by Site Saver, Inc. D/b/a Lineus Medical with the FDA for Safebreak Vascular.

Pre-market Notification Details

DeNovo IDDEN190043
Device Name:SafeBreak Vascular
ClassificationIntravenous Catheter Force-activated Separation Device.
Applicant Site Saver, Inc. D/b/a Lineus Medical 179 N. Church Ave, Suite 202 Fayetteville,  AR  72701
ContactLemuel V. Clement
Product CodeQOI  
CFR Regulation Number880.5220 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGeneral Hospital
Classification AdvisoryGeneral Hospital
TypeDirect
Date Received2019-09-18
Decision Date2021-05-27
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10860635000311 DEN190043 000

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