FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM
K Number: K890047
·
Decision Jun 20, 1989
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
38
Applicant Total
3
Review Days
166
Basic Information
- Device Name
- VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM
- K Number
- K890047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- VASCUCARE, INC.
- Date Received
- January 5, 1989
- Decision Date
- June 20, 1989
- Product Code
- LYK
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| LYK | Angioscope | FDA class 2 | Gastroenterology, Urology |
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