Device Classification Name |
introducer, catheter
|
510(k) Number |
K192313 |
Device Name |
Halo One Thin-Walled Guiding Sheath |
Applicant |
C.R. Bard, Inc. |
Moyne Upper |
Enniscorthy,
IE
|
|
Applicant Contact |
Elizabeth Delahunty |
Correspondent |
C.R. Bard, Inc. |
Moyne Upper |
Enniscorthy,
IE
|
|
Correspondent Contact |
Elizabeth Delahunty |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/26/2019 |
Decision Date | 12/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|