|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
pre-formed blue
|
Lake Region Medical
|
K221575 |
10/07/2022
|
pre-formed extra support guidewire
|
Lake Region Medical
|
K211741 |
11/22/2021
|
hi-torque vektor, .014, 195cm, str, hi-torque vektor, .014, 195cm, j, hi-torque vektor, .014, 300cm, str, hi-torque vektor, .014, 300cm, j
|
Brivant Limited (Lake Region Medical)
|
K182457 |
04/18/2019
|
enroute 0.014 guidewire
|
LAKE REGION MEDICAL
|
K160643 |
10/18/2016
|
pre-formed guidewire
|
Lake Region Medical
|
K151244 |
06/11/2015
|
hi torque connect guidewire, hi torque connect flex guidewire, hi torque connect 250t guidewire
|
LAKE REGION MEDICAL
|
K140536 |
12/17/2014
|
predicate iii guidewire
|
LAKE REGION MEDICAL
|
K142393 |
11/25/2014
|
hydrophilic coated guidewire
|
LAKE REGION MEDICAL
|
K133155 |
04/07/2014
|
mandrel guidewire
|
LAKE REGION MEDICAL
|
K140485 |
03/27/2014
|
pre-formed guidewires
|
LAKE REGION MEDICAL, INC.
|
K130798 |
08/23/2013
|
|