FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUIDE-TECH ENCAPSULATED GUIDEWIRE
K Number: K926039
·
Decision Aug 5, 1993
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
63
Applicant Total
3
Review Days
247
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Basic Information
- Device Name
- GUIDE-TECH ENCAPSULATED GUIDEWIRE
- K Number
- K926039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cape Tech Medical Products
- Date Received
- December 1, 1992
- Decision Date
- August 5, 1993
- Product Code
- KNY
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
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