FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
K Number: K092930
·
Decision Mar 10, 2010
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
16
Review Days
169
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Basic Information
- Device Name
- NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
- K Number
- K092930
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nexus Medical, LLC
- Date Received
- September 22, 2009
- Decision Date
- March 10, 2010
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Nexus Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K142590 | All Safe Huber Safety Infusion Set | Jan 16, 2015 | Substantially Equivalent |
| K133351 | NEXUS NIS-6P LUER ACTIVATED DEVICE | May 22, 2014 | Substantially Equivalent |
| K130879 | NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS | Jul 9, 2013 | Substantially Equivalent |
| 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 |
| 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 |
| K080976 | NEXUS I.V. FLUID TRANSFER DEVICE | Nov 10, 2008 | Substantially Equivalent |
| K062551 | NEXUS IRRIGATION TUBING SET | Dec 15, 2006 | Substantially Equivalent |