14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K030502
Device Name 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
Applicant
MEDCOMP
1499 delp dr.
harleysville, 
PA 
19438

Applicant Contact meghan j tintle
Correspondent
MEDCOMP
1499 delp dr.
harleysville, 
PA 
19438

Correspodent Contact meghan j tintle
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 02/19/2003
Decision Date 05/20/2003
Decision

substantially equivalent

(SESE)

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