XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY


Device Classification Name

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

510(k) Number K111906
Device Name XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Applicant Contact lorraine m hanley
Correspondent
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Correspodent Contact lorraine m hanley
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 07/05/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No