FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORMED II AMBULATORY INFUSION PUMP
K Number: K850674
·
Decision Apr 9, 1985
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
8
Review Days
48
Basic Information
- Device Name
- CORMED II AMBULATORY INFUSION PUMP
- K Number
- K850674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- CORMED, INC., SUB. C.R.BARD, INC.
- Date Received
- February 20, 1985
- Decision Date
- April 9, 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 CORMED, INC., SUB. C.R.BARD, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K863606 | BUTTERFLY NON-CORING NEEDLE SET | Dec 18, 1986 | Substantially Equivalent |
| K860432 | PERCUTANEOUS INTRODUCER KIT | Mar 31, 1986 | Substantially Equivalent |
| K854019 | PORT-GARD | Nov 26, 1985 | Substantially Equivalent |
| K850967 | STERILE CORMED MEDIPORT | May 17, 1985 | Substantially Equivalent |
| K843083 | CORMED HUBER POINT NEEDLE | Sep 5, 1984 | Substantially Equivalent |
| K833915 | VASCULAR ACCESS CATH. REPAIR KIT | Mar 30, 1984 | Substantially Equivalent |
| K823553 | CORCATH H & B VASCULAR ACCESS CATHETER | Jan 5, 1983 | Substantially Equivalent |