CLEANER II ROTATIONAL THROMBECTOMY SYSTEM

Device Classification Name

catheter, peripheral, atherectomy

510(k) Number K033793
Device Name CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
Applicant
REX MEDICAL
55 northern blvd.
suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 12/05/2003
Decision Date 12/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No