FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
K Number: K972206
·
Decision Nov 26, 1997
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
27
Review Days
168
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Basic Information
- Device Name
- NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
- K Number
- K972206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corp.
- Date Received
- June 11, 1997
- Decision Date
- November 26, 1997
- Product Code
- KOC
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
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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
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Blood Tubing Lines for Hemodialysis AV06C-E
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CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
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Other Clearances by Nipro Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K093985 | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | Jan 22, 2010 | Substantially Equivalent |
| K081210 | NIPRO SAFETOUCH HUBER INFUSTION SET | Oct 21, 2008 | Substantially Equivalent |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | Oct 4, 2007 | Substantially Equivalent |
| K063368 | NIPRO BIOHOLE NEEDLE | Feb 5, 2007 | Substantially Equivalent |
| K063721 | NIPRO SAFETOUCH II GAMMA | Jan 12, 2007 | Substantially Equivalent |
| K052474 | NIPRO HYPODERMIC NEEDLE | Nov 10, 2005 | Substantially Equivalent |
| K051574 | NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE | Aug 26, 2005 | Substantially Equivalent |
| K041779 | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L | Sep 21, 2004 | Substantially Equivalent |
| K032777 | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE | Nov 14, 2003 | Substantially Equivalent |
| K030683 | NIPRO DISPOSABLE SYRINGES | Oct 31, 2003 | Substantially Equivalent |