FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE OPTICAL VALVULOTOME
K Number: K924075
·
Decision Feb 8, 1993
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
26
Applicant Total
3
Review Days
180
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE OPTICAL VALVULOTOME
- K Number
- K924075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4885
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endovascular, Inc.
- Date Received
- August 12, 1992
- Decision Date
- February 8, 1993
- Product Code
- MGZ
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| MGZ | Valvulotome | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGZ), ordered by most recent decision date.
LimFlow Vector
FDA 510(k)
FDA Class 2
·Cardiovascular
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
FDA 510(k)
FDA Class 2
·Cardiovascular
LimFlow Vector
FDA 510(k)
FDA Class 2
·Cardiovascular
EZE SIT Valvulotome
FDA 510(k)
FDA Class 2
·Cardiovascular
Antegrade LeMills Valvulotome
FDA 510(k)
FDA Class 2
·Cardiovascular
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular