Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K142445 |
Device Name |
PINPOINT GT SAFETY INTRODUCER NEEDLE |
Applicant |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
AMY MCMANUS |
Correspondent |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
SALT LAKE CITY,
UT
84116
|
|
Correspondent Contact |
AMY MCMANUS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/02/2014 |
Decision Date | 04/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|