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FDA 510(k) Applications Submitted by Luke Meidell
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140398
02/18/2014
EMBOL-X INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC.
K211525
05/17/2021
SwiftNINJA Steerable Microcatheter
Merit Medical Systems, Inc.
K131627
06/04/2013
CATHETER INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC.
K191608
06/17/2019
Impress Angiographic Catheter
Merit Medical Systems, Inc.
K161921
07/13/2016
SwiftNINJA Microcatheter
MERIT MEDICAL SYSTEMS, INC.
K132175
07/15/2013
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
EDWARDS LIFESCIENCES, LLC.
K123714
12/04/2012
EDWARDS EMBOL-X INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC.
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