FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
K Number: K111884
·
Decision Jul 29, 2011
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
25
Applicant Total
25
Review Days
28
Basic Information
- Device Name
- OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
- K Number
- K111884
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4885
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LEMAITRE VASCULAR, INC.
- Date Received
- July 1, 2011
- Decision Date
- July 29, 2011
- 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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Other Clearances by LEMAITRE VASCULAR, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K152833 | Pruitt F3-S Polyurethane Carotid Shunt | Jan 21, 2016 | Substantially Equivalent |
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | Apr 10, 2014 | Substantially Equivalent |
| K133026 | UNBALLOON NON-OCCLUSION MODELING CATHETER | Dec 31, 2013 | Substantially Equivalent |
| K132022 | LEMAITRE 8F OCCLUSION CATHETER | Nov 6, 2013 | Substantially Equivalent |
| K132047 | LEMILLS VALVULOTOME | Nov 5, 2013 | Substantially Equivalent |
| K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | Aug 5, 2013 | Substantially Equivalent |
| K130016 | LIFESPAN EPTFE VASCULAR GRAFT | Feb 5, 2013 | Substantially Equivalent |
| K123531 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER | Dec 14, 2012 | Substantially Equivalent |
| K121415 | MOLLRING MULTITASC | Sep 5, 2012 | Substantially Equivalent |
| K103080 | ALBOGRAFT VASCULAR PROSTHESIS | Jan 19, 2011 | Substantially Equivalent |