FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Auryon Atherectomy System
K Number: K260244
·
Decision Apr 10, 2026
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
1
Review Days
73
Basic Information
- Device Name
- Auryon Atherectomy System
- K Number
- K260244
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eximo Medical
- Date Received
- January 27, 2026
- Decision Date
- April 10, 2026
- Product Code
- MCW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCW), ordered by most recent decision date.
FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
FDA 510(k)
FDA Class 2
·Cardiovascular
Turbo-Elite Laser Atherectomy Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Rotarex Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
FreedomFlow Orbital Circumferential Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
FDA 510(k)
FDA Class 2
·Cardiovascular
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
FDA 510(k)
FDA Class 2
·Cardiovascular