Versa-Cath Arterial Catheter
FDA 510(k) K961883 · Ideas For Medicine, Inc.
510(k) numberK961883
Submission
- Device name
- Versa-Cath Arterial Catheter
- Applicant
- Ideas For Medicine, Inc.
Pinellas Park, FL, US - Received
- May 15, 1996
- Decision date
- January 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K962751 | Ideas' Dual PortLJT · Traditional | 09/30/1996SE |
| K961716 | Vaso-Safe Arterial Embolectomy CatheteDXE · Traditional | 09/19/1996SE |
| K960715 | Pruitt-Inahara Carotid Shunt 400-40-8F/INAHARA-PRUITT Carotid Shunt 500-50-8FMJN · Traditional | 09/09/1996SE |
| K960422 | Pruitt Safety Occlusion CatheterMJN · Traditional | 08/07/1996SE |
| K954713 | Dural-Lumen Intra Vascular Balloon Catheter (Modification)FGE · Traditional | 07/24/1996SE |
| K935964 | Ideas OccluderDXC · Traditional | 01/04/1995SE |
| K935023 | Godat Uterine Manipulator InjectorLKF · Traditional | 01/04/1995SE |
| K880231 | Modified Pruitt Irrigation & Occlusion CatheterDQT · Traditional | 05/25/1988SE |
| K872090 | The Robicsek - Pruitt Aortic Balloon Occlusion KitDQT · Traditional | 10/30/1987SE |
| K872485 | Change of Catheter Body Material (Radio-Opaque Ny)DXE · Traditional | 08/12/1987SE |
Questions and answers
When was Versa-Cath Arterial Catheter cleared by the FDA?
Versa-Cath Arterial Catheter (K961883) received a 510(k) decision of Substantially Equivalent on January 13, 1997, 243 days after the submission was received.
What is the product code of K961883?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.