URETERAL ACCESS SHEATH SET (UASS)


Device Classification Name

catheter, urological

510(k) Number K022135
Device Name URETERAL ACCESS SHEATH SET (UASS)
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760

Original Contact janet a mcgrath
Regulation Number 876.5130
Classification Product Code
KOD  
Subsequent Product Code
KOG  
Date Received 07/01/2002
Decision Date 09/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls