EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER


Device Classification Name

catheters, transluminal coronary angioplasty, percutaneous

510(k) Number K110133
Device Name EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
Applicant
CREGANNA-TACTX MEDICAL
1353 dell avenue
campbell, 
CA 
95008

Applicant Contact dennis wong
Correspondent
CREGANNA-TACTX MEDICAL
1353 dell avenue
campbell, 
CA 
95008

Correspodent Contact dennis wong
Regulation Number 870.5100
Classification Product Code
LOX  
Date Received 01/18/2011
Decision Date 06/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls