CLC2000 CATHETER PATENCY DEVICE


Device Classification Name

set, administration, intravascular

510(k) Number K021692
Device Name CLC2000 CATHETER PATENCY DEVICE
Original Applicant
ICU MEDICAL, INC.
951 calle amanecer
san clemente, 
CA 
92673

Original Contact alison d burcar
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 05/22/2002
Decision Date 12/04/2003
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