FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADD-A-VIAL SOLUTION TRANSFER DEVICE
K Number: K843639
·
Decision Jan 14, 1985
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
13
Review Days
119
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Basic Information
- Device Name
- ADD-A-VIAL SOLUTION TRANSFER DEVICE
- K Number
- K843639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- American Mcgaw
- Date Received
- September 17, 1984
- Decision Date
- January 14, 1985
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by American Mcgaw
| K Number | Device Name | ||
|---|---|---|---|
| K853549 | MCGAW/DROP WATCH FLOW MONITOR | Nov 12, 1985 | Substantially Equivalent |
| K843954 | MIXING CONTAINER | Nov 28, 1984 | Substantially Equivalent |
| K841729 | ACCUPRO ENTERAL FEEDING PUMP | Jun 1, 1984 | Substantially Equivalent |
| K840212 | CONCENTRATED PLATELET ADMIN. SET | Mar 6, 1984 | Substantially Equivalent |
| K840388 | PAB IV CONTAINER | Mar 6, 1984 | Substantially Equivalent |
| K831716 | CAPD - CATHETER ADAPTER | Jun 24, 1983 | Substantially Equivalent |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | Dec 30, 1982 | Substantially Equivalent |
| K820133 | MCGAW FAT EMULSION SET | Apr 6, 1982 | Substantially Equivalent |
| K813092 | ACCUPRO I.V. ADMINISTRATION SET | Dec 31, 1981 | Substantially Equivalent |
| K810683 | CAPD CATHETER ADAPTER | May 8, 1981 | Substantially Equivalent |