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510(k) K223486

SafeBreak® Vascular by Lineus Medical — Product Code QOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2023
Date Received
November 21, 2022
Clearance Type
Traditional
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 by Lineus Medical

  • K231957 — SafeBreak® Vascular (September 29, 2023)
  • K222791 — SafeBreak Vascular (October 16, 2022)

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)
  • K230266 — Orchid Safety Release Valve (May 4, 2023)
  • K222791 — SafeBreak Vascular (October 16, 2022)
  • K212064 — Orchid Safety Release Valve(TM) (May 3, 2022)
  • DEN190043 — SafeBreak Vascular (May 27, 2021)