FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NAC PRN NEEDLELESS ACCESS CONNECTOR
K Number: K992268
·
Decision Sep 15, 1999
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
6
Review Days
71
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Basic Information
- Device Name
- NAC PRN NEEDLELESS ACCESS CONNECTOR
- K Number
- K992268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Kipp Group
- Date Received
- July 6, 1999
- Decision Date
- September 15, 1999
- 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 The Kipp Group
| K Number | Device Name | ||
|---|---|---|---|
| K000343 | NAC Y-ADP | Mar 1, 2000 | Substantially Equivalent |
| K000152 | KIPPMED I.V. MANIFOLD | Feb 29, 2000 | Substantially Equivalent |
| K993147 | DECAP | Nov 2, 1999 | Substantially Equivalent |
| K991932 | INTRAVASCULAR ADMINISTRATION SET | Aug 20, 1999 | Substantially Equivalent |
| K970255 | KIPP MED I.V. MANIFOLD | Apr 14, 1997 | Substantially Equivalent |