Nikkiso Co., Ltd.
Medical device manufacturer in Tokyo, JP.
11510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | 05/15/2025SE |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | 05/15/2025SE |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)KDI · Traditional | 05/15/2025SE |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-EKOC · Traditional | 07/28/2023SE |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…KOC · Traditional | 06/16/2023SE |
| K152938 | DBB-06 Hemodialysis Delivery SystemKDI · Traditional | 03/18/2016SE |
| K091978 | DBB-06 Hemodialysis Delivery SystemKDI · Traditional | 03/25/2010SE |
| K082719 | Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-PKOC · Traditional | 03/30/2009SE |
| K061519 | Modification to DBB-05 Hemodialysis Delivery SystemKDI · Special | 09/28/2007SE |
| K953996 | Nikkiso Co, Ltd., FLX10GW, 12GW, 15GW, 18GW & 21GW HemodialyzersKDI · Traditional | 03/19/1997SE |
| K803068 | Nikkiso ND-14 Parallel Flow DialyzerFJG · Traditional | 03/04/1981SE |