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)— 510(k) K233668

Clearance details

Applicant

Eximo Medical, Ltd.

Product code

Code MCW

Device class

Class 2

Regulation

21 CFR 870.4875

Advisory panel

Cardiovascular

Date received

2023-11-15

Decision date

2023-12-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Rehovot, IL

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Death

38

Injury

1,386

Malfunction

2,676

Other

2

Total

4,102

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →