THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K110891
Device Name THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER
Applicant
LEMAITRE VASCULAR INC.
63 second avenue
burlington, 
MA 
01803

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

Correspodent Contact andrew hodgkinson
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 03/30/2011
Decision Date 09/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No