3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON


Device Classification Name

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

510(k) Number K030270
Device Name 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON
Original Applicant
MEDCOMP
1499 delp dr.
harleysville, 
PA 
19438

Original Contact meghan j tintle
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 01/27/2003
Decision Date 04/11/2003
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