REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406


Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K024243
Device Name REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406
Original Applicant
FOX HOLLOW TECHNOLOGIES
300 saginaw dr.
redwood city, 
CA 
94063

Original Contact suzon lommel
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 12/23/2002
Decision Date 06/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls