Medical Device Manufacturer · IL , Rehovot

Eximo Medical, Ltd.

7 submissions · 7 cleared · Since 2018
7
Total
7
Cleared
0
Denied

Eximo Medical, Ltd. — FDA 510(k) Submissions

Eximo Medical, Ltd. has submitted 7 FDA 510(k) premarket notifications since 2018, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Peripheral, Atherectomy . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
K241553 · MCW Catheter, Peripheral,... · Cardiovascular
Jun 2024 27d
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-4011-0000)
K233668 · MCW Catheter, Peripheral,... · Cardiovascular
Dec 2023 30d
Auryon Atherectomy System
K230709 · MCW Catheter, Peripheral,... · Cardiovascular
Jun 2023 87d
Auryon Atherectomy Catheters
K220116 · MCW Catheter, Peripheral,... · Cardiovascular
Sep 2022 255d
Auryon Atherectomy System
K221077 · MCW Catheter, Peripheral,... · Cardiovascular
Jun 2022 58d
Auryon Atherectomy System
K202835 · MCW Catheter, Peripheral,... · Cardiovascular
Dec 2020 68d
B-Laser Atherectomy System
K181642 · MCW Catheter, Peripheral,... · Cardiovascular
Oct 2018 106d
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