CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER


Device Classification Name

dilator, esophageal

510(k) Number K023907
Device Name CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER
Original Applicant
CORDIS CORP.
7 powder horn dr.
warren, 
NJ 
07059

Original Contact donna marshall
Regulation Number 876.5365
Classification Product Code
KNQ  
Date Received 11/25/2002
Decision Date 12/18/2002
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