PICC CONVENIENCE KIT


Device Classification Name

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

510(k) Number K121990
Device Name PICC CONVENIENCE KIT
Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Applicant Contact marion w gordon
Correspondent
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Correspodent Contact marion w gordon
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 07/06/2012
Decision Date 08/03/2012
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

Recalls CDRH Recalls