FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROFUSE INTRAVENOUS CATHETER SET
K Number: K840240
·
Decision Apr 17, 1984
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
39
Review Days
88
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Basic Information
- Device Name
- MICROFUSE INTRAVENOUS CATHETER SET
- K Number
- K840240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Norton Performance Plastics Corp.
- Date Received
- January 20, 1984
- Decision Date
- April 17, 1984
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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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 |
| K851299 | CORRECT FLO | May 7, 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 |
| 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 |