MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER


Device Classification Name

catheters, transluminal coronary angioplasty, percutaneous

510(k) Number K110617
Device Name MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
Applicant
Abbott Vascular
26531 ynez road
temecula, 
CA 
92591

Applicant Contact suzanne redman
Correspondent
Abbott Vascular
26531 ynez road
temecula, 
CA 
92591

Correspodent Contact suzanne redman
Regulation Number 870.5100
Classification Product Code
LOX  
Date Received 03/03/2011
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Clinical Trials NCT01186198
Reviewed by Third Party No

Combination Product

No