NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER


Device Classification Name

catheter,intravascular,therapeutic,long-term greater than 30 days

510(k) Number K110627
Device Name NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
Applicant
MARVAO MEDICAL DEVICES, LTD.
368 west main street
suite 7
northboro, 
MA 
01532

Applicant Contact marybeth gamber
Correspondent
MARVAO MEDICAL DEVICES, LTD.
368 west main street
suite 7
northboro, 
MA 
01532

Correspodent Contact marybeth gamber
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 03/04/2011
Decision Date 08/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No