FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DESERET PRN ADAPTER
K Number: K893406
·
Decision Jun 22, 1989
Classifications
1
FEI Numbers
214
Registration Numbers
214
Same Product Code
28
Applicant Total
20
Review Days
51
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Basic Information
- Device Name
- DESERET PRN ADAPTER
- K Number
- K893406
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Deseret Medical, Inc.
- Date Received
- May 2, 1989
- Decision Date
- June 22, 1989
- Product Code
- KGZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGZ | Accessories, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGZ), ordered by most recent decision date.
AART SILICONE TUBING
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BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
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WOUND DRAINAGE HOLDER
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DURALASTIC SILICONE TUBING
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NAVARRE PERCUTANEOUS ACCESS SET
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FDA Class 1
·General, Plastic Surgery
PALESTRANT IRRIGATION AND DRAINAGE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K882797 | LUER-LOK MULTIFLO ADAPTER | Jul 18, 1988 | Substantially Equivalent |
| K882798 | MULTIFLO ADAPTER | Jul 18, 1988 | Substantially Equivalent |