Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K150232 |
Device Name |
Radifocus Optitorque Angiographic Catheter |
Applicant |
ASHITAKA FACTORY OF TERUMO CORP. |
150 MAIMAIGI-CHO |
FUJINOMIYA, SHIZUOKA,
JP
418-0015
|
|
Applicant Contact |
Monika McDole-Russell |
Correspondent |
TERUMO MEDICAL CORP. |
265 Davidson Ave., Suite 320 |
Somerset,
NJ
08873
|
|
Correspondent Contact |
Monika McDole-Russell |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 02/02/2015 |
Decision Date | 10/19/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|