OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME


Device Classification Name

valvulotome

510(k) Number K111884
Device Name OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
Applicant
LEMAITRE VASCULAR, INC.
63 2nd avenue
burlington, 
MA 
01803

Applicant Contact andrew hodgkinson
Correspondent
LEMAITRE VASCULAR, INC.
63 2nd avenue
burlington, 
MA 
01803

Correspodent Contact andrew hodgkinson
Regulation Number 870.4885
Classification Product Code
MGZ  
Date Received 07/01/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No