FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
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)
K Number: K233668
·
Decision Dec 15, 2023
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- 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)
- K Number
- K233668
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eximo Medical, Ltd.
- Date Received
- November 15, 2023
- Decision Date
- December 15, 2023
- 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 |
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Other Clearances by Eximo Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Jun 27, 2024 | Substantially Equivalent |
| K230709 | Auryon Atherectomy System | Jun 9, 2023 | Substantially Equivalent |
| K220116 | Auryon Atherectomy Catheters | Sep 26, 2022 | Substantially Equivalent |
| K221077 | Auryon Atherectomy System | Jun 9, 2022 | Substantially Equivalent |
| K202835 | Auryon Atherectomy System | Dec 2, 2020 | Substantially Equivalent |
| K181642 | B-Laser Atherectomy System | Oct 5, 2018 | Substantially Equivalent |