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FDA 510(k) Applications Submitted by Yoel Zabar
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220116
01/14/2022
Auryon Atherectomy Catheters
Eximo Medical Ltd.
K230709
03/14/2023
Auryon Atherectomy System
Eximo Medical Ltd.
K221077
04/12/2022
Auryon Atherectomy System
Eximo Medical Ltd.
K241553
05/31/2024
Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
Eximo Medical, Ltd.
K202835
09/25/2020
Auryon Atherectomy System
Eximo Medical Ltd.
K233668
11/15/2023
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011
Eximo Medical, Ltd.
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