Device Listing 1354271202

Listing Summary#

Listing key
1354271202
Premarket submission
K233668
Device
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)
Applicant
Eximo Medical, Ltd.
Product code
MCW
Decision date
2023-12-15