SAFEFLO VENA CAVA FILTER


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K081138
Device Name SAFEFLO VENA CAVA FILTER
Applicant
RMT MEDICAL TECHNILOGIES INC.
1835 market street
suite 200
philadelphia, 
PA 
19103

Applicant Contact janice m hogan
Correspondent
RMT MEDICAL TECHNILOGIES INC.
1835 market street
suite 200
philadelphia, 
PA 
19103

Correspodent Contact janice m hogan
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 04/21/2008
Decision Date 05/07/2009
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No