Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K161183 |
Device Name |
Halo One Thin-Walled Guiding Sheath |
Applicant |
C.R. BARD, INC |
MOYNE UPPER |
ENNISCORTHY,
IE
|
|
Applicant Contact |
FIONA NI MHULLAIN |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 04/27/2016 |
Decision Date | 06/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|