Amplatz Goose-Neck Snare
FDA 510(k) K901502 · Microvena Corp.
510(k) numberK901502
Submission
- Device name
- Amplatz Goose-Neck Snare
- Applicant
- Microvena Corp.
Findley, MN, US - Received
- March 29, 1990
- Decision date
- December 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXE – Catheter, Embolectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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| K241330 | Fogarty Fortis Arterial Embolectomy CatheterDXE · Traditional | Edwards Lifesciences | 07/02/2024SE |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate ValveDXE · Traditional | Edwards Lifesciences | 05/22/2024SE |
| K233819 | Fogarty Venous Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences, LLC | 05/22/2024SE |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences | 05/20/2024SE |
| K213771 | Merlin Aspiration SystemDXE · Traditional | Mivi Neurovascular, Inc. | 01/27/2022SE |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE · Special | Applied Medical Resources Corporation | 09/07/2021SE |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeDXE · Traditional | Edwards Lifesciences, LLC | 06/12/2020SE |
| K163031 | Bunegin-Albin Air Aspiration SetDXE · Traditional | Cook Incorporated | 07/27/2017SE |
| K163353 | Needle's Eye Snare Retrieval Set - 54cmDXE · Special | Cook Incorporated | 07/11/2017SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
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| 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 |
| K954205 | The Amplatz Thrombectomy DeviceMCW · Traditional | 08/13/1996SE |
| K955304 | CricketDQX · Traditional | 05/16/1996SE |
| K952860 | The Niner Nitinol GuidewireDQX · Traditional | 12/13/1995SE |
Questions and answers
When was Amplatz Goose-Neck Snare cleared by the FDA?
Amplatz Goose-Neck Snare (K901502) received a 510(k) decision of Substantially Equivalent on December 3, 1990, 249 days after the submission was received.
What is the product code of K901502?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.