SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING


Device Classification Name

wire, guide, catheter

510(k) Number K073162
Device Name SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING
Applicant
KENSEY NASH CORPORATION
735 pennsylvania drive
exton, 
PA 
19341

Applicant Contact robin fatzinger
Correspondent
KENSEY NASH CORPORATION
735 pennsylvania drive
exton, 
PA 
19341

Correspodent Contact robin fatzinger
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 11/09/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No