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 ID: DEN190043
• Device Name: SafeBreak Vascular
• Classification: Intravenous Catheter Force-activated Separation Device.
• Applicant: Site Saver, Inc. D/b/a Lineus Medical 179 N. Church Ave, Suite 202 Fayetteville, AR 72701
• Contact: Lemuel V. Clement
• Product Code: QOI
• CFR Regulation Number: 880.5220 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: General Hospital
• Classification Advisory: General Hospital
• Type: Direct
• Date Received: 2019-09-18
• Decision Date: 2021-05-27
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10860635000311	DEN190043	000