FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
K Number: K850183
·
Decision Mar 13, 1985
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
9
Review Days
54
Basic Information
- Device Name
- CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
- K Number
- K850183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- DELTEC SYSTEMS, INC.
- Date Received
- January 18, 1985
- Decision Date
- March 13, 1985
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by DELTEC SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K871132 | PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS | Apr 20, 1987 | Substantially Equivalent |
| K870768 | AC ADAPTER ACCESSORY, PRODUCT CODE 600123A | Mar 13, 1987 | Substantially Equivalent |
| K862927 | CADD-1, MODEL 5100 HF | Aug 27, 1986 | Substantially Equivalent |
| K854964 | CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. | Mar 7, 1986 | Substantially Equivalent |
| K853584 | CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP | Nov 12, 1985 | Substantially Equivalent |
| K843773 | CADD-PAC 5200 AMBULATORY INFUSION PUMP | Dec 6, 1984 | Substantially Equivalent |
| K843772 | CADD-1 5100 AMBULATORY INFUSION PUMP | Dec 6, 1984 | Substantially Equivalent |
| K833949 | MICRO INFUSION SET | Jan 11, 1984 | Substantially Equivalent |