OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302


Device Classification Name

catheter, embolectomy

510(k) Number K022145
Device Name OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
Original Applicant
LEMAITRE VASCULAR, INC.
26 ray ave.
burlington, 
MA 
01803

Original Contact james ashby
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 07/02/2002
Decision Date 01/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No