VASU-PICC


Device Classification Name

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

510(k) Number K122423
Device Name VASU-PICC
Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville, 
PA 
19438

Applicant Contact jessica leo
Correspondent
MEDICAL COMPONENTS INC
1499 delp drive
harleysville, 
PA 
19438

Correspodent Contact jessica leo
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 08/09/2012
Decision Date 12/12/2012
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