510(k) K220568
- Device
- Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
- Applicant
- Cardiovascualr Systems Inc.
- 510(k) number
- K220568
- Product code
- MCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-27
- Date received
- 2022-02-28
- Regulation
- 870.4875
- Classification name
- Catheter, Peripheral, Atherectomy
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kris Miller
- Address
- 1225 Old Hwy. 8 NW St.Paul MN US 55112 55112
FDA Registration Numbers#
- 3003708554
- 1225687
- 1061124
- 3020968442
- 3010173425
- 2648045
- 2244478
- 2939520
- 3010273872
- 3009756153
- 3010280625
- 3004091615
- 3008814558
- 3012669557
- 3032916632
- 3007284006
- 9616684
- 2134265
- 3002807314
- 2024311
- 3004859241
- 1721676
- 1625425
- 3003780911
- 3016445722
- 3000279201
- 3016257349
- 1724474
- 2183870
- 1000121056
- 3011137372
- 3004742232
- 3006702495
- 3003862657
- 3007048256
- 3015124694
- 3014443747
- 3010041511
- 3002631703
- 1643817
- 3006946276
- 9612164
- 3008439199
- 3014254831
- 2124215
- 3000126629
- 3017896194
- 2011171
- 3007695959
- 3038165043
- 2020394
- 2183744
- 3008363989
Source Documents#
Other 510(k) Records For Product Code MCW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260244 | Auryon Atherectomy System | Eximo Medical | 2026-04-10 |
| K250723 | FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc., | 2025-04-25 |
| K250385 | Turbo-Elite Laser Atherectomy Catheter | Spectranetics | 2025-03-13 |
| K242757 | Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. | 2025-01-30 |
| K242947 | FreedomFlow™ Orbital Circumferential Atherectomy System | Cardio Flow Inc., | 2024-11-05 |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical, Ltd. | 2024-06-27 |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | Cardio Flow Inc., | 2024-02-15 |
| 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) | Eximo Medical, Ltd. | 2023-12-15 |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | 2023-09-27 |
| K230709 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2023-06-09 |
| K230005 | Pantheris LV Atherectomy Catheter | Avinger, Inc. | 2023-06-06 |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics, Inc. | 2022-12-08 |
| K220116 | Auryon Atherectomy Catheters | Eximo Medical, Ltd. | 2022-09-26 |
| K220962 | ROTAPRO Rotational Atherectomy System | Boston Scientific Corporation | 2022-09-06 |
| K221077 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2022-06-09 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases