FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
K Number: K061519
·
Decision Sep 28, 2007
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
11
Review Days
484
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Basic Information
- Device Name
- MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
- K Number
- K061519
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NIKKISO CO., LTD.
- Date Received
- June 1, 2006
- Decision Date
- September 28, 2007
- Product Code
- KDI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by NIKKISO CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| 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) | May 15, 2025 | Substantially Equivalent |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | May 15, 2025 | Substantially Equivalent |
| 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 | May 15, 2025 | Substantially Equivalent |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | Jul 28, 2023 | Substantially Equivalent |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | Jun 16, 2023 | Substantially Equivalent |
| K152938 | DBB-06 Hemodialysis Delivery System | Mar 18, 2016 | Substantially Equivalent |
| K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM | Mar 25, 2010 | Substantially Equivalent |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P | Mar 30, 2009 | Substantially Equivalent |
| K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS | Mar 19, 1997 | Substantially Equivalent |
| K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER | Mar 4, 1981 | Substantially Equivalent |