Device Classification Name |
catheters, transluminal coronary angioplasty, percutaneous
|
510(k) Number |
K141025 |
Device Name |
ARTIMES BALLOON DILATATION CATHETER |
Applicant |
BROSMED MEDICAL |
15TH-BUILDING,SMES VENTURE PARK,SONGSHAN LAKE HI-TECH |
DEVELOPMENT ZONE |
DONGGUAN, GUANGDONG,
CN
523808
|
|
Applicant Contact |
STEPHEN LEE |
Correspondent |
BROSMED MEDICAL |
15TH-BUILDING,SMES VENTURE PARK,SONGSHAN LAKE HI-TECH |
DEVELOPMENT ZONE |
DONGGUAN, GUANGDONG,
CN
523808
|
|
Correspondent Contact |
STEPHEN LEE |
Regulation Number | 870.5100
|
Classification Product Code |
|
Date Received | 04/21/2014 |
Decision Date | 09/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|