SPLIT CATH III


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K111651
Device Name SPLIT CATH III
Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville, 
PA 
19438

Applicant Contact jean callow
Correspondent
MEDICAL COMPONENTS INC
1499 delp drive
harleysville, 
PA 
19438

Correspodent Contact jean callow
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 06/13/2011
Decision Date 12/08/2011
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