ARROW PICC POWERED BY ARROW VPS STYLET


Device Classification Name

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

510(k) Number K121941
Device Name ARROW PICC POWERED BY ARROW VPS STYLET
Applicant
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 bernville rd.
reading, 
PA 
19605

Applicant Contact elizabeth duncan
Correspondent
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
2400 bernville rd.
reading, 
PA 
19605

Correspodent Contact elizabeth duncan
Regulation Number 880.5970
Classification Product Code
LJS  
Subsequent Product Code
OBJ  
Date Received 07/02/2012
Decision Date 09/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls