Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K111556 |
Device Name |
GLIDECROSS SUPPORT CATHETER |
Applicant |
TERUMO MEDICAL CORP. |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Applicant Contact |
MARK UNTERREINER |
Correspondent |
TERUMO MEDICAL CORP. |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Correspondent Contact |
MARK UNTERREINER |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/06/2011 |
Decision Date | 07/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|