Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
FDA 510(k) clearance K241553 · decided 2024-06-27
Clearance details
- K-number
- K241553
- Device name
- Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
- Applicant
- Eximo Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-31
- Decision date
- 2024-06-27
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100 recall (Z-0770-2025) | Angiodynamics, Inc. | 2024-12-27 |