NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K111900
Device Name NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
Applicant
Teleflex Medical, Inc.
2400 bernville road
reading, 
PA 
19605

Applicant Contact suzanne schorle
Correspondent
Teleflex Medical, Inc.
2400 bernville road
reading, 
PA 
19605

Correspodent Contact suzanne schorle
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 07/05/2011
Decision Date 08/17/2011
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