Texan Longhorn Foreign Body Retrieval Device, Model TX30120060
FDA 510(k) K050926 · Idev Technologies, Inc.
510(k) numberK050926
Submission
- Device name
- Texan Longhorn Foreign Body Retrieval Device, Model TX30120060
- Applicant
- Idev Technologies, Inc.
Houston, TX, US - Received
- April 13, 2005
- Decision date
- May 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMX – Device, Percutaneous Retrieval
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
Other 510(k)s with product code MMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242776 | LimFlow V-CeiverMMX · Special | LimFlow, Inc. | 02/14/2025SE |
| K241259 | Amplatz Goose Neck Snare KitMMX · Special | Medtronic, Inc. | 06/03/2024SE |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitMMX · Special | Argon Medical Devices, Inc. | 09/07/2023SE |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval SetMMX · Traditional | Cook Incorporated | 05/16/2023SE |
| K222083 | LimFlow V-CeiverMMX · Traditional | LimFlow, Inc. | 08/09/2022SE |
| K212988 | ONO Retrieval DeviceMMX · Traditional | Onocor Vascular, LLC | 05/23/2022SE |
| K213494 | Aveir Retrieval CatheterMMX · Traditional | Abbott Medical | 04/01/2022SE |
| K200963 | Halo Single-Loop Microsnare KitMMX · Traditional | Argon Medical Devices, Inc. | 01/05/2021SE |
| K200268 | Halo Single-Loop Snare KitMMX · Traditional | Argon Medical Devices, Inc. | 06/03/2020SE |
| K193507 | Merit ONE Snare SystemMMX · Special | Merit Medical Systems, Inc. | 01/17/2020SE |
More from Merit Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130591 | Supera VeritasFGE · Traditional | 05/02/2013SESU |
| K122546 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 12/07/2012SESU |
| K111627 | Supera Veritas(R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 08/21/2012SESU |
| K111766 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsFGE · Traditional | 10/19/2011SESU |
| K093893 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 10/05/2010SESU |
| K071646 | Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…FGE · Traditional | 01/31/2008SESU |
| K060557 | Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery CATHETER-SS06120060FGE · Traditional | 08/15/2006SESU |
| K041374 | Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060QEW · Traditional | 03/02/2005SE |
| K033188 | Texan Foreign Body Retrieval Device, Model TX30060050MMX · Traditional | 11/19/2003SE |
| K030504 | Akonya Eliminator Mechanical Thrombectomy Device, Model El 10060060MCW · Traditional | 09/16/2003SE |
Questions and answers
When was Texan Longhorn Foreign Body Retrieval Device, Model TX30120060 cleared by the FDA?
Texan Longhorn Foreign Body Retrieval Device, Model TX30120060 (K050926) received a 510(k) decision of Substantially Equivalent on May 9, 2005, 26 days after the submission was received.
What is the product code of K050926?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.