Hollow Motor Drive Unit W/ Torque Controller
FDA 510(k) K920707 · Devices For Vascular Intervention, Inc.
510(k) numberK920707
Submission
- Device name
- Hollow Motor Drive Unit W/ Torque Controller
- Applicant
- Devices For Vascular Intervention, Inc.
Redwood City, CA, US - Received
- February 18, 1992
- Decision date
- November 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
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|---|---|---|---|
| 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 |
|---|---|---|
| K935929 | MicrotrackMCW · Traditional | 03/10/1994SE |
| K914422 | Devices for Vascu Intervent Rotat Hemostat ValveDQY · Traditional | 12/18/1991SE |
| K911678 | Rotating Hemostatic ValveDYB · Traditional | 07/12/1991SE |
| K910205 | LP-60 Low Pressure Inflation DeviceMAV · Traditional | 02/25/1991SE |
| K901601 | Hollow Motor Drive UnitLIT · Traditional | 07/06/1990SE |
| K883933 | Introducing CatheterDYB · Traditional | 12/02/1988SE |
| K883981 | Guiding Catheter (Tip Softness Change)DWF · Traditional | 11/03/1988SE |
| K883916 | Rotating Hemostatic ValveDQY · Traditional | 10/28/1988SE |
| K883346 | Simpson Peripheral Atherocath W/Addit. Size 13FLIT · Traditional | 09/26/1988SE |
| K881088 | Addition of a Tip Guard to the Atherocath(Tm)LIT · Traditional | 05/31/1988SE |
Questions and answers
When was Hollow Motor Drive Unit W/ Torque Controller cleared by the FDA?
Hollow Motor Drive Unit W/ Torque Controller (K920707) received a 510(k) decision of Substantially Equivalent on November 23, 1992, 279 days after the submission was received.
What is the product code of K920707?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.