FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTINUOUS FLUSH DEVICE, CAT. #14-370
K Number: K791890
·
Decision Dec 13, 1979
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
170
Applicant Total
39
Review Days
79
Basic Information
- Device Name
- CONTINUOUS FLUSH DEVICE, CAT. #14-370
- K Number
- K791890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- NORTON PERFORMANCE PLASTICS CORP.
- Date Received
- September 25, 1979
- Decision Date
- December 13, 1979
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |