The Amplatz Thrombectomy Device
FDA 510(k) K954205 · Microvena Corp.
510(k) numberK954205
Submission
- Device name
- The Amplatz Thrombectomy Device
- Applicant
- Microvena Corp.
White Bear Lake, MN, US - Received
- September 7, 1995
- Decision date
- August 13, 1996
- 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 |
|---|---|---|
| K991898 | Ultra-Select Guidewire, Hytek GuidewireDQX · Special | 06/16/1999SE |
| K991194 | Modification to Ultra-Select GuidewireDQX · Special | 05/05/1999SE |
| K982657 | Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal…MCW · Traditional | 11/18/1998SE |
| K970668 | The Amplantz Goose Neck MicrosnareDQY · Traditional | 06/10/1998SE |
| K972511 | Amplatz Goose Neck Snare Kit/ CatheterDXE · Traditional | 03/06/1998SE |
| K971984 | Amplatz Thrombectomy Device(Atd 603,602,801,802)/FOOT Pedal Assembly(Ak 200)MCW · Traditional | 09/19/1997SE |
| K954642 | Hydro-Select GuidewireDQX · Traditional | 12/17/1996SE |
| K955304 | CricketDQX · Traditional | 05/16/1996SE |
| K952860 | The Niner Nitinol GuidewireDQX · Traditional | 12/13/1995SE |
| K946356 | M-Path Nitinol GuidewireDQX · Traditional | 03/31/1995SE |
Questions and answers
When was The Amplatz Thrombectomy Device cleared by the FDA?
The Amplatz Thrombectomy Device (K954205) received a 510(k) decision of Substantially Equivalent on August 13, 1996, 341 days after the submission was received.
What is the product code of K954205?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.