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
|
|
Correspondent Contact |
DENNIS WONG |
Regulation Number | 870.5100
|
Classification Product Code |
|
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
|
|
|