Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating— 510(k) K241553
Substantially EquivalentEximo Medical, Ltd.
FDA 510(k) clearance K241553 for Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating, Substantially Equivalent on 2024-06-27. Applicant: Eximo Medical, Ltd.. Device class: 2.
Clearance details
- Applicant
- Eximo Medical, Ltd.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rehovot, IL
Recent devices under product code MCW
view allMore clearances from Eximo Medical, Ltd.
view all- K233668 — 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)
- K230709 — Auryon Atherectomy System
- K220116 — Auryon Atherectomy Catheters
- K221077 — Auryon Atherectomy System
- K202835 — Auryon Atherectomy System
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K241553
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241553.
Data sourced from openFDA. This site is unofficial and independent of the FDA.