Pantheris LV Atherectomy Catheter
FDA 510(k) K230005 · Avinger, Inc.
510(k) numberK230005
Submission
- Device name
- Pantheris LV Atherectomy Catheter
- Applicant
- Avinger, Inc.
Redwood City, CA, US - Received
- January 3, 2023
- Decision date
- June 6, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Other 510(k)s with product code MCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260244 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical | 04/10/2026SE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | Cardio Flow Inc., | 04/25/2025SE |
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | Spectranetics | 03/13/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | Bard Peripheral Vascular, Inc. | 01/30/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | Cardio Flow Inc., | 11/05/2024SE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special | Eximo Medical, Ltd. | 06/27/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | Cardio Flow Inc., | 02/15/2024SE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special | Eximo Medical, Ltd. | 12/15/2023SE |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Traditional | Cardio Flow Inc., | 09/27/2023SE |
| K230709 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 06/09/2023SE |
More from Eximo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | 04/25/2023SE |
| K212468 | Tigereye CTO-Crossing CatheterPDU · Traditional | 01/06/2022SE |
| K212047 | Pantheris SystemMCW · Traditional | 11/16/2021SE |
| K201330 | Tigereye CTO-Crossing CatheterPDU · Traditional | 09/10/2020SE |
| K182341 | Pantheris SVMCW · Traditional | 04/09/2019SE |
| K173862 | Pantheris SystemMCW · Traditional | 05/22/2018SE |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…MCW · Special | 10/30/2017SE |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledMCW · Special | 12/21/2016SE |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledMCW · Traditional | 10/18/2016SE |
| K160827 | Pantheris CatheterMCW · Special | 04/21/2016SE |
Questions and answers
When was Pantheris LV Atherectomy Catheter cleared by the FDA?
Pantheris LV Atherectomy Catheter (K230005) received a 510(k) decision of Substantially Equivalent on June 6, 2023, 154 days after the submission was received.
What is the product code of K230005?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.