510(k) K233820
- Device
- Fogarty Arterial Embolectomy Catheter with Gate Valve
- Applicant
- Edwards Lifesciences
- 510(k) number
- K233820
- Product code
- DXE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-22
- Date received
- 2023-12-01
- Regulation
- 870.5150
- Classification name
- Catheter, Embolectomy
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Yagna Angirish
- Address
- 1 Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers
- 2024311
- 1018233
- 1061124
- 3013666218
- 2183870
- 9617465
- 2015691
- 3010041511
- 2183744
- 3035111606
- 2648045
- 2029386
- 9680794
- 3030714660
- 9615817
- 3008496528
- 8043983
- 2522007
- 3005704822
- 3006082230
- 3011137372
- 3032916632
- 1220452
- 1220948
- 1721504
- 1000393132
- 1820334
- 2027111
- 1721686
- 3015859709
- 1319639
- 3009051888
- 3012050423
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DXE
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences, LLC | 2024-08-28 |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences | 2024-07-02 |
| K233819 | Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC | 2024-05-22 |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences | 2024-05-20 |
| K213771 | Merlin Aspiration System | Mivi Neurovascular, Inc. | 2022-01-27 |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Applied Medical Resources Corporation | 2021-09-07 |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | Edwards Lifesciences, LLC | 2020-06-12 |
| K163031 | Bunegin-Albin Air Aspiration Set | Cook Incorporated | 2017-07-27 |
| K163353 | Needle's Eye Snare Retrieval Set - 54cm | Cook Incorporated | 2017-07-11 |
| K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2015-09-18 |
| K100840 | EMBO PLUS EMBOLECTOMY CATHETER | Hotspur Technologies | 2010-07-12 |
| K100842 | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM | Hotspur Technologies | 2010-07-12 |
| K081573 | MEDTRONIC EXPORT AP CATHETER | Medtronic Vascular | 2008-06-27 |
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | LeMaitre Vascular, Inc. | 2003-01-14 |
| K020634 | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | 2002-05-08 |