FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE FOLEY CATHETERS & UROLOGICAL
K Number: K831743
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
41
Review Days
104
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Basic Information
- Device Name
- STERILE FOLEY CATHETERS & UROLOGICAL
- K Number
- K831743
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Electromedics, Inc.
- Date Received
- May 31, 1983
- Decision Date
- September 12, 1983
- Product Code
- KOD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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| K930154 | EL2-SERIES BLOOD COLLECTION REERVOIR | Jul 1, 1993 | Substantially Equivalent |
| K926250 | ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR | Feb 19, 1993 | Substantially Equivalent |
| K925412 | ELECTROMEDICS TISSUE TRAP/ #TT280 | Feb 5, 1993 | Substantially Equivalent |
| K915737 | AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR | Sep 3, 1992 | Substantially Equivalent |
| K910238 | PORTABLE AUTO TRANSFUSION SYSTEM 500 | Jun 19, 1991 | Substantially Equivalent |
| K910935 | MODIFIED PYROGEN TESTING | May 16, 1991 | Substantially Equivalent |
| K902723 | ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 | Dec 13, 1990 | Substantially Equivalent |