FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORRECT FLO
K Number: K851299
·
Decision May 7, 1985
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
39
Review Days
36
Basic Information
- Device Name
- CORRECT FLO
- K Number
- K851299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- NORTON PERFORMANCE PLASTICS CORP.
- Date Received
- April 1, 1985
- Decision Date
- May 7, 1985
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by NORTON PERFORMANCE PLASTICS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K853791 | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 | Dec 9, 1985 | Substantially Equivalent |
| K852914 | ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION | Sep 25, 1985 | Substantially Equivalent |
| K842858 | FLUID ADMINISTRATION LINE W/SPIKE 14-923 | Sep 11, 1984 | Substantially Equivalent |
| K841828 | CENTRAL VENOUS CATHETER W/BIG-GARD | Jul 13, 1984 | Substantially Equivalent |
| K840240 | MICROFUSE INTRAVENOUS CATHETER SET | Apr 17, 1984 | Substantially Equivalent |
| K831587 | TEMP. REPAIR KIT-DUAL LUMEN CATHETER | Oct 19, 1983 | Substantially Equivalent |
| K831698 | DISPOSABLE PRESSURE TRANSDUCER#14004195 | Aug 11, 1983 | Substantially Equivalent |
| K830788 | CENTRAL VEIN CATHERIZATION KIT-14-690- | Apr 30, 1983 | Substantially Equivalent |
| K830813 | FRENCH PERCUTANEOUS SHEATH INTRODUCER | Apr 28, 1983 | Substantially Equivalent |
| K830969 | PERM. REPAIR KIT FOR LEONARD NORTON DUAL | Apr 14, 1983 | Substantially Equivalent |