FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VESSEL DILATOR
K Number: K913027
·
Decision Nov 27, 1991
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
20
Review Days
141
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Basic Information
- Device Name
- VESSEL DILATOR
- K Number
- K913027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deseret Medical, Inc.
- Date Received
- July 9, 1991
- Decision Date
- November 27, 1991
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| 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 |
| K882798 | MULTIFLO ADAPTER | Jul 18, 1988 | Substantially Equivalent |