TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS


Device Classification Name

catheter, hemodialysis, non-implanted

510(k) Number K022221
Device Name TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
Original Applicant
DELTEC, INC.
1265 grey fox rd.
st. paul, 
MN 
55112

Original Contact lisa stone
Regulation Number 876.5540
Classification Product Code
MPB  
Subsequent Product Code
MSD  
Date Received 07/09/2002
Decision Date 01/30/2003
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