OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME— 510(k) K111884
Substantially EquivalentLeMaitre Vascular, Inc.
FDA 510(k) clearance K111884 for OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME, Substantially Equivalent on 2011-07-29. Applicant: LeMaitre Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- LeMaitre Vascular, Inc.
- Product code
- Code MGZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4885
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
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