HEMO-STREAM HEMODIALYSIS CATHETER SET


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K023847
Device Name HEMO-STREAM HEMODIALYSIS CATHETER SET
Original Applicant
REX MEDICAL
55 northern blvd.
suite 200
great neck, 
NY 
11021

Original Contact susan d goldstein-falk
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 11/19/2002
Decision Date 04/30/2003
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

Recalls CDRH Recalls