FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOLEY CATHETER
K Number: K870165
·
Decision Apr 17, 1987
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
1
Review Days
93
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Basic Information
- Device Name
- FOLEY CATHETER
- K Number
- K870165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Acorn Medical Products
- Date Received
- January 14, 1987
- Decision Date
- April 17, 1987
- 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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