NC TREK RX CORONARY DILATATION CATHETER


Device Classification Name

catheters, transluminal coronary angioplasty, percutaneous

510(k) Number K110134
Device Name NC TREK RX CORONARY DILATATION CATHETER
Applicant
ABBOTT VASCULAR-CARDIAC THERAPIES
26531 ynez rd.
mailing p.o. box 9018
temecula, 
CA 
92589 -9018

Applicant Contact suzanne redman
Correspondent
ABBOTT VASCULAR-CARDIAC THERAPIES
26531 ynez rd.
mailing p.o. box 9018
temecula, 
CA 
92589 -9018

Correspodent Contact suzanne redman
Regulation Number 870.5100
Classification Product Code
LOX  
Date Received 01/18/2011
Decision Date 02/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No