FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIO-FLO
K Number: K790327
·
Decision Feb 26, 1979
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
20
Review Days
10
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Basic Information
- Device Name
- ANGIO-FLO
- K Number
- K790327
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Deseret Medical, Inc.
- Date Received
- February 16, 1979
- Decision Date
- February 26, 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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Other Clearances by Deseret Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913027 | VESSEL DILATOR | Nov 27, 1991 | Substantially Equivalent |
| K904648 | SAFE SYTE I.V. CATHETER PLACEMENT UNIT | Dec 14, 1990 | Substantially Equivalent |
| K904121 | VIALON OBTURATOR | Nov 8, 1990 | Substantially Equivalent |
| K904122 | INSYTE-A ARTERIAL CATHETERIZATION UNIT | Oct 4, 1990 | Substantially Equivalent |
| K900116 | DESERET OPTIMA INTRAVASCULAR CATHETER | Jun 18, 1990 | Substantially Equivalent |
| K895735 | DESERET MULTILUMEN SUBCLAVIAN CATHETER | May 18, 1990 | Substantially Equivalent |
| K895734 | DESERET INTRAVASCULAR CATHETER | Apr 9, 1990 | Substantially Equivalent |
| K894033 | DISPOSABLE CATHETER PRESSURE TRANSDUCER | Oct 17, 1989 | Substantially Equivalent |
| K893406 | DESERET PRN ADAPTER | Jun 22, 1989 | Substantially Equivalent |
| K882797 | LUER-LOK MULTIFLO ADAPTER | Jul 18, 1988 | Substantially Equivalent |