FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET
K Number: K902858
·
Decision Dec 14, 1990
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
18
Review Days
168
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Basic Information
- Device Name
- AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET
- K Number
- K902858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- 3M Avi, Inc.
- Date Received
- June 29, 1990
- Decision Date
- December 14, 1990
- 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 3M Avi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912069 | AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET | Oct 14, 1993 | Substantially Equivalent |
| K912589 | AVI MODEL 840D DUAL CHANNEL INFUSION PUMP | Oct 17, 1991 | Substantially Equivalent |
| K912590 | AVI MODEL 400D INFUSION PUMP | Oct 17, 1991 | Substantially Equivalent |
| K912591 | AVI MICRO 210D INFUSION PUMP | Sep 6, 1991 | Substantially Equivalent |
| K912875 | AVI MODEL 270CI INFUSION PUMP | Aug 20, 1991 | Substantially Equivalent |
| K912738 | AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS | Aug 12, 1991 | Substantially Equivalent |
| K912031 | AVI MODEL 870 DUAL CHANNEL INFUSION PUMP | Jun 18, 1991 | Substantially Equivalent |
| K904979 | AVI MODEL 600 SYRINGE PUMP, MODIFICATION | Jan 15, 1991 | Substantially Equivalent |
| K903786 | AVI MICRO 845 DUAL CHANNEL INFUSION PUMP | Sep 5, 1990 | Substantially Equivalent |
| K903782 | AVI MODEL 270CM INFUSION PUMP | Sep 5, 1990 | Substantially Equivalent |