Device Classification Name |
introducer, catheter
|
510(k) Number |
K111606 |
Device Name |
PINNACLE PRECISION ACCESS SYSTEM |
Applicant |
TERUMO MEDICAL CORP. |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Applicant Contact |
DANIEL R PLONSKI |
Correspondent |
TERUMO MEDICAL CORP. |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Correspondent Contact |
DANIEL R PLONSKI |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 06/09/2011 |
Decision Date | 10/03/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|