Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model Ak 100
FDA 510(k) K982657 · Microvena Corp.
510(k) numberK982657
Submission
- Device name
- Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model Ak 100
- Applicant
- Microvena Corp.
White Bear Lake, MN, US - Received
- July 30, 1998
- Decision date
- November 18, 1998
- 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
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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 |
|---|---|---|
| K991898 | Ultra-Select Guidewire, Hytek GuidewireDQX · Special | 06/16/1999SE |
| K991194 | Modification to Ultra-Select GuidewireDQX · Special | 05/05/1999SE |
| 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 |
| K954205 | The Amplatz Thrombectomy DeviceMCW · Traditional | 08/13/1996SE |
| 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 Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model Ak 100 cleared by the FDA?
Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model Ak 100 (K982657) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 111 days after the submission was received.
What is the product code of K982657?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.