FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MiniMed Quick-serter
K Number: K160860
·
Decision Sep 22, 2016
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
48
Review Days
177
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Basic Information
- Device Name
- MiniMed Quick-serter
- K Number
- K160860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Minimed
- Date Received
- March 29, 2016
- Decision Date
- September 22, 2016
- Product Code
- KZH
- 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 |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | FDA class 2 | General Hospital |
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| K052432 | MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 | Nov 29, 2005 | Substantially Equivalent |