Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5150](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5150) → DXE — Catheter, Embolectomy # DXE · Catheter, Embolectomy _Cardiovascular · 21 CFR 870.5150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE ## Overview - **Product Code:** DXE - **Device Name:** Catheter, Embolectomy - **Regulation:** [21 CFR 870.5150](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5150) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 74) Showing 20 most recent of 74 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K240078](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K240078.md) | Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences, LLC | Aug 28, 2024 | SESE | | [K241330](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K241330.md) | Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences | Jul 2, 2024 | SESE | | [K233820](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K233820.md) | Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences | May 22, 2024 | SESE | | [K233819](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K233819.md) | Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC | May 22, 2024 | SESE | | [K233619](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K233619.md) | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences | May 20, 2024 | SESE | | [K213771](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K213771.md) | Merlin Aspiration System | Mivi Neurovascular, Inc. | Jan 27, 2022 | SESE | | [K202049](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K202049.md) | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Applied Medical Resources Corporation | Sep 7, 2021 | SESE | | [K193379](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K193379.md) | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | Edwards Lifesciences, LLC | Jun 12, 2020 | SESE | | [K163031](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K163031.md) | Bunegin-Albin Air Aspiration Set | Cook Incorporated | Jul 27, 2017 | SESE | | [K163353](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K163353.md) | Needle's Eye Snare Retrieval Set - 54cm | Cook Incorporated | Jul 11, 2017 | SESE | | [K152335](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K152335.md) | Export Advance Aspiration Catheter | Medtronic, Inc. | Sep 18, 2015 | SESE | | [K100842](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K100842.md) | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM | Hotspur Technologies | Jul 12, 2010 | SESE | | [K100840](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K100840.md) | EMBO PLUS EMBOLECTOMY CATHETER | Hotspur Technologies | Jul 12, 2010 | SESE | | [K081573](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K081573.md) | MEDTRONIC EXPORT AP CATHETER | Medtronic Vascular | Jun 27, 2008 | SESE | | [K022145](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K022145.md) | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | LeMaitre Vascular, Inc. | Jan 14, 2003 | SESE | | [K020634](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K020634.md) | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | May 8, 2002 | SESE | | [K011783](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K011783.md) | MULTI-SNARE SET | Pfm Produkte Fur Die Medizin AG | Jan 24, 2002 | SESE | | [K002627](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K002627.md) | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | Apr 26, 2001 | SESE | | [K992933](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K992933.md) | LEMAITRE IRRIGATION CATHETER | Vascutech, Inc. | Mar 8, 2000 | SESE | | [K992934](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K992934.md) | LEMAITRE VENOUS THROMBECTOMY CATHETER | Vascutech, Inc. | Mar 1, 2000 | SESE | ## Top Applicants - Shiley, Inc. — 5 clearances - Cathlab Corp. — 4 clearances - Ideas For Medicine, Inc. — 4 clearances - Lucas Medical, Inc. — 4 clearances - Vascutech, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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