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FDA 510(k) Applications for Medical Device Product Code "QOI"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K232094
Linear Health Sciences LLC
Orchid Safety Release ValveTM
10/03/2023
K230266
Linear Health Sciences, LLC
Orchid Safety Release Valve
05/04/2023
K212064
Linear Health Sciences, LLC
Orchid Safety Release Valve(TM)
05/03/2022
K223486
Lineus Medical
SafeBreak« Vascular
05/19/2023
K231957
Lineus Medical
SafeBreak« Vascular
09/29/2023
K222791
Lineus Medical, LLC
SafeBreak Vascular
10/16/2022
DEN190043
Site Saver, Inc. d/b/a Lineus Medical
SafeBreak Vascular
05/27/2021
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