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510(k) DEN190043

SafeBreak Vascular by Site Saver, Inc. D/B/A Lineus Medical — Product Code QOI

DEN190043 is an FDA 510(k) premarket notification submitted by Site Saver, Inc. D/B/A Lineus Medical for the device "SafeBreak Vascular". The FDA issued a decision of De Novo Granted on May 27, 2021. The device falls under product code QOI (Intravenous Catheter Force-Activated Separation Device.), a Class II device regulated under 21 CFR 880.5220.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 27, 2021
Date Received
September 18, 2019
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intravenous Catheter Force-Activated Separation Device.
Device Class
Class II
Regulation Number
880.5220
Review Panel
HO
Submission Type

An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.

Other clearances for product code QOI

  • K241415 — Orchid Safety Release Valve™ (September 6, 2024)
  • K232094 — Orchid Safety Release ValveTM (October 3, 2023)
  • K231957 — SafeBreak® Vascular (September 29, 2023)
  • K223486 — SafeBreak® Vascular (May 19, 2023)
  • K230266 — Orchid Safety Release Valve (May 4, 2023)
  • K222791 — SafeBreak Vascular (October 16, 2022)
  • K212064 — Orchid Safety Release Valve(TM) (May 3, 2022)

FDA data resources