Diamondback 360 Degree Orbital Atherectomy System for Treatment of A-V Shunt Stenosis
FDA 510(k) K071427 · Cardiovascular Systems, Inc.
510(k) numberK071427
Submission
- Device name
- Diamondback 360 Degree Orbital Atherectomy System for Treatment of A-V Shunt Stenosis
- Applicant
- Cardiovascular Systems, Inc.
Saint Paul, MN, US - Received
- May 23, 2007
- Decision date
- August 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…MCW · Special | 03/01/2022SE |
| K212725 | ViperCross Support CathetersDQY · Special | 09/24/2021SE |
| K210586 | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…MCW · Special | 09/14/2021SE |
| K211240 | ViperCross Support CathetersDQY · Traditional | 08/26/2021SE |
| K211251 | ViperCath XC Peripheral Exchange CatheterDQY · Special | 05/26/2021SE |
| K210282 | WIRION Embolic Protection SystemNTE · Special | 03/03/2021SE |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…MCW · Traditional | 11/19/2020SE |
| K200198 | WirionNTE · Traditional | 03/18/2020SE |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…MCW · Traditional | 07/02/2019SE |
| K183000 | ViperCath XC Peripheral Exchange CatheterDQY · Traditional | 12/29/2018SE |
Questions and answers
When was Diamondback 360 Degree Orbital Atherectomy System for Treatment of A-V Shunt Stenosis cleared by the FDA?
Diamondback 360 Degree Orbital Atherectomy System for Treatment of A-V Shunt Stenosis (K071427) received a 510(k) decision of Substantially Equivalent on August 30, 2007, 99 days after the submission was received.
What is the product code of K071427?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.