STONE EXTRACTOR BALLOON CATHETER


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K011261
Device Name STONE EXTRACTOR BALLOON CATHETER
Original Applicant
MEDI-GLOBE CORP.
6202 south maple ave. # 131
tempe, 
AZ 
85283

Original Contact scott karler
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 04/25/2001
Decision Date 11/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No