NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE


Device Classification Name

catheter, embolectomy

510(k) Number K110315
Device Name NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
Applicant
NEXGEN MEDICAL SYSTEMS, INC.
1050 w. nasa blvd.
suite 136
melbourne, 
FL 
32901

Applicant Contact craig pagan
Correspondent
NEXGEN MEDICAL SYSTEMS, INC.
1050 w. nasa blvd.
suite 136
melbourne, 
FL 
32901

Correspodent Contact craig pagan
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 02/02/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No