Identity
- Trade Name
- Auryon Atherectomy Catheter FDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
- Device Name
- Auryon Atherectomy Catheter 1.7mm OTW FDA UDI
- Model / Reference
- EXM-4012-0000 FDA UDI
- Description
- Auryon Atherectomy Catheter 1.7mm OTW FDA UDI
Identifiers
- Catalog Number
- EXM-4012-0000 FDA UDI
- Primary DI / UDI-DI
- 07290017590332 FDA UDI
- 510(k) Number
- K241553 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.7 Millimeter FDA UDILength — 150 Centimeter FDA UDI
Category: Atherectomy laser system beam guide-catheter, peripheral
Auryon Atherectomy Catheter by Eximo Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atherectomy laser system beam guide-catheter, peripheral.
- Turbo-Elite™ — Spectranetics Corporation · Class II
- NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC. · Class II
- DABRA 101 Catheter — Catheter Precision, Inc · Class II
- NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC. · Class II
- Turbo-Power™ — Spectranetics Corporation · Class II
- NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter — NORTHEAST SCIENTIFIC, INC. · Class II
- Turbo-Elite™ — Spectranetics Corporation · Class II
- Turbo-Power™ — Spectranetics Corporation · Class II
Cleared under the same submission
K241553 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eximo Medical Ltd
Sources (1)
- FDA UDI f0f97d9f-8879-43cc-bb17-d07f7c3239a9 38 fields · synced Jun 1, 2026