FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZE SIT Valvulotome
K Number: K190267
·
Decision Oct 30, 2019
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
26
Applicant Total
3
Review Days
264
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Basic Information
- Device Name
- EZE SIT Valvulotome
- K Number
- K190267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4885
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lemaitre Vascular
- Date Received
- February 8, 2019
- Decision Date
- October 30, 2019
- 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 |
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