SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT


Device Classification Name

dilator, vessel

510(k) Number K022620
Device Name SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
Original Applicant
SPIRE BIOMEDICAL, INC.
one patriots park
bedford, 
MA 
01730 -2396

Original Contact donald fickett
Regulation Number 876.5540
Classification Product Code
FKA  
Date Received 08/07/2002
Decision Date 10/11/2002
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