FDA 510(k) Applications Submitted by Nikkiso Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230514 |
02/24/2023 |
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series |
Nikkiso Co., Ltd. |
| K231589 |
06/01/2023 |
Blood Tubing Lines for Hemodialysis AV06C-E |
Nikkiso Co., Ltd. |
| K242155 |
07/23/2024 |
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) |
NIKKISO CO., LTD. |
| K242176 |
07/24/2024 |
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) |
Nikkiso Co., LTD. |
| K242479 |
08/21/2024 |
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-PU |
Nikkiso Co., LTD. |
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