FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEXUS I.V. FLUID TRANSFER DEVICE
K Number: K080976
·
Decision Nov 10, 2008
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
16
Review Days
217
Basic Information
- Device Name
- NEXUS I.V. FLUID TRANSFER DEVICE
- K Number
- K080976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nexus Medical, LLC
- Date Received
- April 7, 2008
- Decision Date
- November 10, 2008
- Product Code
- LHI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K130416 | NEXUS TKO-6P LUER ACTIVATED DEVICE | Jun 12, 2013 | Substantially Equivalent |
| K113398 | NEXUS TKO-6, LUER-ACTIVATED DEVICE | Apr 18, 2012 | Substantially Equivalent |
| K092382 | NEXUS PRESSURE RATED EXTENSION SETS | Apr 26, 2010 | Substantially Equivalent |
| K092930 | NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED | Mar 10, 2010 | Substantially Equivalent |
| K092527 | NEXUS INJECTION SITE, MODEL NIS-8 | Feb 4, 2010 | Substantially Equivalent |
| K081123 | NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS | Nov 14, 2008 | Substantially Equivalent |
| K062551 | NEXUS IRRIGATION TUBING SET | Dec 15, 2006 | Substantially Equivalent |