Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K113335 |
Device Name |
HEARTRAIL III GUIDING CATHETER |
Applicant |
TERUMO Corporation |
44-1, 2-CHOME HATAGAYA |
SHIBUYA-KU TOKYO,
JP
151-0072
|
|
Applicant Contact |
MARK UNTERREINER |
Correspondent |
TERUMO Corporation |
44-1, 2-CHOME HATAGAYA |
SHIBUYA-KU TOKYO,
JP
151-0072
|
|
Correspondent Contact |
MARK UNTERREINER |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 11/14/2011 |
Decision Date | 07/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|