24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K021212
Device Name 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
Original Applicant
SPIRE BIOMEDICAL INC
one patriots park
bedford, 
MA 
01730

Original Contact donald fickett
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 04/17/2002
Decision Date 05/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No