14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K021759
Device Name 14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
Original Applicant
MEDCOMP
1499 delp dr.
harleysville, 
PA 
19438

Original Contact florence a caikoski
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 05/29/2002
Decision Date 08/27/2002
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No