FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SmartSite Vented Vial Access Device
K Number: K151963
·
Decision Jul 31, 2015
Classifications
1
FEI Numbers
176
Registration Numbers
176
Same Product Code
200
Applicant Total
5
Review Days
15
Basic Information
- Device Name
- SmartSite Vented Vial Access Device
- K Number
- K151963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- YUKON MEDICAL, LLC
- Date Received
- July 16, 2015
- Decision Date
- July 31, 2015
- Product Code
- LHI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
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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Other Clearances by YUKON MEDICAL, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K132863 | SMARTSITE VIALSHIELD | Oct 4, 2013 | Substantially Equivalent |
| K122265 | VIALOK SINGLE VIAL ACCESS DEVICE VENTED | Aug 14, 2012 | Substantially Equivalent |
| K121182 | VIALOK NON-VENTED | May 3, 2012 | Substantially Equivalent |
| K120799 | ARISURE NEUTRAL VALVE | Mar 30, 2012 | Substantially Equivalent |