TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815


Device Classification Name

wire, guide, catheter

510(k) Number K022357
Device Name TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
Original Applicant
BOSTON SCIENTIFIC, TARGET
47900 bayside pkwy.
fremont, 
CA 
94538

Original Contact george j prendergast
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 07/19/2002
Decision Date 10/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No