Device Classification Name |
introducer, catheter
|
510(k) Number |
K052185 |
Device Name |
DESTINATION CAROTID GUIDING SHEATH |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
MARK UNTERREINER |
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
MARK UNTERREINER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/11/2005 |
Decision Date | 09/06/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|