FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATIVE CARE SYSTEMS' IV START KIT
K Number: K863796
·
Decision Nov 28, 1986
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
29
Applicant Total
6
Review Days
60
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Basic Information
- Device Name
- CREATIVE CARE SYSTEMS' IV START KIT
- K Number
- K863796
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- American Biomaterials Corp.
- Date Received
- September 29, 1986
- Decision Date
- November 28, 1986
- Product Code
- LRS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRS | I.V. Start Kit | FDA class 2 | General Hospital |
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Other Clearances by American Biomaterials Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K922455 | EVERT-O-CATH CATHETER | Jul 7, 1994 | Substantially Equivalent |
| K924725 | AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS | Feb 5, 1993 | Substantially Equivalent |
| K915824 | HOLE PUNCH | Jan 29, 1993 | Substantially Equivalent |
| K880371 | BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER | Nov 18, 1988 | Substantially Equivalent |
| K843461 | BIOGLASS OSSICULAR RECONSTRUCTION PROSTH | Jan 9, 1985 | Substantially Equivalent |