FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NON-KOR WINGED INFUSION SETS
K Number: K861406
·
Decision May 6, 1986
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
7
Review Days
21
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Basic Information
- Device Name
- NON-KOR WINGED INFUSION SETS
- K Number
- K861406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Creative Care Systems, Inc.
- Date Received
- April 15, 1986
- Decision Date
- May 6, 1986
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Creative Care Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852831 | NON-KOR ACCESS KITS | Sep 19, 1985 | Unknown |
| K850888 | PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV | May 7, 1985 | Substantially Equivalent |
| K850887 | DRESSING CHANGE KIT | May 1, 1985 | Substantially Equivalent |
| K841742 | NON-CORING NEEDLE | Jul 6, 1984 | Substantially Equivalent |
| K840919 | DAYPAK SYS VII CATHETER CARE KIT | Apr 17, 1984 | Substantially Equivalent |
| K840681 | DAYPAK SYSTEM III CATHETER CARE KIT | Apr 16, 1984 | Substantially Equivalent |