PRESSURE INJECTABLE PICC


Device Classification Name

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

510(k) Number K073451
Device Name PRESSURE INJECTABLE PICC
Applicant
ARROW INTERNATIONAL, INC.
2400 bernville rd.
reading, 
PA 
19605

Applicant Contact kevin lentz
Correspondent
ARROW INTERNATIONAL, INC.
2400 bernville rd.
reading, 
PA 
19605

Correspodent Contact kevin lentz
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 12/10/2007
Decision Date 01/15/2008
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