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510(k) K232094

Orchid Safety Release ValveTM by Linear Health Sciences, LLC — Product Code QOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2023
Date Received
July 13, 2023
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 Linear Health Sciences, LLC

  • K241415 — Orchid Safety Release Valve™ (September 6, 2024)
  • K230266 — Orchid Safety Release Valve (May 4, 2023)
  • K212064 — Orchid Safety Release Valve(TM) (May 3, 2022)

Other clearances for product code QOI

  • K241415 — Orchid Safety Release Valve™ (September 6, 2024)
  • 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)
  • DEN190043 — SafeBreak Vascular (May 27, 2021)