PRESSURE INJFECTABLE PICC


Device Classification Name

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

510(k) Number K080604
Device Name PRESSURE INJFECTABLE PICC
Applicant
ARROW INTERNATIONAL, INC.
2400 bernville rd.
reading, 
PA 
19605

Applicant Contact julie lawson
Correspondent
ARROW INTERNATIONAL, INC.
2400 bernville rd.
reading, 
PA 
19605

Correspodent Contact julie lawson
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 03/04/2008
Decision Date 06/27/2008
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