J-Lloyd Arterial Embolectomy Catheter
FDA 510(k) K920871 · J-Lloyd Medical, Inc.
510(k) numberK920871
Submission
- Device name
- J-Lloyd Arterial Embolectomy Catheter
- Applicant
- J-Lloyd Medical, Inc.
West Berlin, NJ, US - Received
- February 25, 1992
- Decision date
- February 26, 1993
- 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 |
|---|---|---|
| K973639 | Electrode Semi-Flotation Catheter by J-Lloyd Medical, Inc.DRF · Traditional | 04/20/1998SE |
| K971504 | Hexapolar Electrode Balloon Flotation CatheterDRF · Traditional | 04/20/1998SE |
| K974336 | Cholangiograph Balloon Catheter by J-Lloyd Medical, Inc.GCJ · Traditional | 02/13/1998SE |
| K974335 | Embolectomy, Irrigation - Occlusion Balloon Catheter by J-Lloyd Medical, Inc.DXE · Traditional | 02/13/1998SE |
| K963248 | Flow Directed Thermodilution/Infusion Balloon Catheter (575-110P)DYG · Traditional | 02/03/1997SE |
| K950440 | Dual Function Pacing Wedge Pressure Balloon Catheter by J-LloydDQO · Traditional | 09/15/1995SE |
| K940547 | Flow Direct Thermodilut Balloon Cath Heparin CoatedDYG · Traditional | 08/11/1994SE |
| K935405 | Arterial EmbolectomyDXE · Traditional | 07/25/1994SE |
| K935403 | Wedge Pressure Balloon Catheter by J-LloydDQO · Traditional | 05/12/1994SE |
| K935404 | Flow Directed Thermodilution Balloon CatheterDYG · Traditional | 05/03/1994SE |
Questions and answers
When was J-Lloyd Arterial Embolectomy Catheter cleared by the FDA?
J-Lloyd Arterial Embolectomy Catheter (K920871) received a 510(k) decision of Substantially Equivalent on February 26, 1993, 367 days after the submission was received.
What is the product code of K920871?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.