Shear Force Gauge
FDA 510(k) K864330 · American Edwards Laboratories
510(k) numberK864330
Submission
- Device name
- Shear Force Gauge
- Applicant
- American Edwards Laboratories
Santa Ana, CA, US - Received
- November 4, 1986
- Decision date
- January 6, 1987
- 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
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 |
|---|---|---|
| K873485 | Edslab (R) Occlusion Balloon CatheterDQY · Traditional | 12/03/1987SE |
| K872596 | Trantec Disposable Pressure TRANS.53-600/F/F30DRS · Traditional | 09/30/1987SE |
| K872529 | Thermodilution Cardiac Output Computer, Mod. COM-2DXG · Traditional | 09/15/1987SE |
| K870444 | Homepro II Volumetric Infusion PumpFRN · Traditional | 04/17/1987SE |
| K864997 | Medtrac VP Volumetric Infusion PumpFRN · Traditional | 02/27/1987SE |
| K862724 | Vein Valve CutterDQY · Traditional | 01/02/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | 11/20/1986SE |
| K863596 | Chin-Fogarty Inflation DeviceDXT · Traditional | 11/20/1986SE |
| K863986 | Xenon Light Source for Endoscopic ProceduresHRX · Traditional | 10/31/1986SE |
| K862872 | Flexible Visualization CatheterFEI · Traditional | 10/24/1986SE |
Questions and answers
When was Shear Force Gauge cleared by the FDA?
Shear Force Gauge (K864330) received a 510(k) decision of Substantially Equivalent on January 6, 1987, 63 days after the submission was received.
What is the product code of K864330?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.