|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
low profile companion sheath
|
Merit Medical Systems, Inc.
|
K223872 |
01/19/2023
|
prelude guide sheath
|
Merit Medical Systems, Inc.
|
K211405 |
10/04/2021
|
prelude ideal hydrophilic sheath introducer
|
Merit Medical Systems, Inc.
|
K173750 |
02/15/2018
|
prelude pursuit splittable sheath introducer
|
Merit Medical Systems, Inc.
|
K172117 |
09/11/2017
|
heartspan steerable sheath introducer
|
Merit Medical Systems, Inc.
|
K170668 |
04/05/2017
|
prelude snap splittable hydrophilic sheath introducer
|
MERIT MEDICAL SYSTEMS, INC.
|
K152381 |
10/30/2015
|
5.5 f worley advanced lvi lateral vein introducer
|
MERIT MEDICAL SYSTEMS, INC.
|
K152116 |
08/27/2015
|
preludeease hydrophilic sheath introducer
|
Merit Medical Systems, Inc.
|
K150257 |
06/19/2015
|
prelude snap splittable sheath introducer
|
MERIT MEDICAL SYSTEMS, INC.
|
K143255 |
04/09/2015
|
preludeease hydrophilic sheath introducer
|
MERIT MEDICAL SYSTEMS, INC.
|
K140543 |
10/16/2014
|