DBB-06 HEMODIALYSIS DELIVERY SYSTEM— 510(k) K091978
Substantially EquivalentNIKKISO CO., LTD.
FDA 510(k) clearance K091978 for DBB-06 HEMODIALYSIS DELIVERY SYSTEM, Substantially Equivalent on 2010-03-25. Applicant: NIKKISO CO., LTD.. Device class: 2.
Clearance details
- Applicant
- NIKKISO CO., LTD.
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code KDI
view allMore clearances from NIKKISO CO., LTD.
view all- K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
- 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)
- 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-PU
- K231589 — Blood Tubing Lines for Hemodialysis AV06C-E
- K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
Adverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K091978
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091978.
Data sourced from openFDA. This site is unofficial and independent of the FDA.