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FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2025-05-15
TypeNumberDevice NameCodeDateActions
510(k) K242155 DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)KDI2025-05-15 View
510(k) K242479 BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUKOC2025-05-15 View
510(k) K242176 BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)KOC2025-05-15 View
510(k) K231589 Blood Tubing Lines for Hemodialysis AV06C-EKOC2023-07-28 View
510(k) K230514 Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesKOC2023-06-16 View
510(k) K152938 DBB-06 Hemodialysis Delivery SystemKDI2016-03-18 View
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