Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K162769 |
Device Name |
Pinpoint GT Introducer Needle |
Applicant |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
Salt Lake City,
UT
84116
|
|
Applicant Contact |
Jamie Howell |
Correspondent |
C.R. BARD, INC. |
605 NORTH 5600 WEST |
Salt Lake City,
UT
84116
|
|
Correspondent Contact |
Jamie Howell |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 10/03/2016 |
Decision Date | 11/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|