Lmi Arterial Embolectomy Catheter
FDA 510(k) K954760 · Lucas Medical, Inc.
510(k) numberK954760
Submission
- Device name
- Lmi Arterial Embolectomy Catheter
- Applicant
- Lucas Medical, Inc.
Anaheim, CA, US - Received
- October 17, 1995
- Decision date
- April 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXE – Catheter, Embolectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
Other 510(k)s with product code DXE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy CatheterDXE · Traditional | Edwards Lifesciences, LLC | 08/28/2024SE |
| 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 |
|---|---|---|
| K983802 | Lmi Carotid Endarterectomy Shunt Catheter, Model #'S Ces, Cesr, Cesb, Cesrb, Cest…MJN · Traditional | 07/30/1999SE |
| K972623 | Lmi Irrigation Catheter (Igr)DXE · Traditional | 11/19/1997SE |
| K970657 | Lmi Thrombectomy CatheterDXE · Traditional | 07/01/1997SE |
| K955126 | Lmi Biliary CatheterFGE · Traditional | 05/10/1996SE |
| K955125 | Lmi Occlusion CatheterDXE · Traditional | 03/11/1996SE |
| K955499 | Lmi Bilumen Irrigation Arterial Embolectomy CahteterMJN · Traditional | 02/28/1996SE |
Questions and answers
When was Lmi Arterial Embolectomy Catheter cleared by the FDA?
Lmi Arterial Embolectomy Catheter (K954760) received a 510(k) decision of Substantially Equivalent on April 11, 1996, 177 days after the submission was received.
What is the product code of K954760?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.