Product Code: NTE FDA class 2 21 CFR 870.1250

Temporary Carotid Catheter For Embolic Capture

Cardiovascular

The Temporary Carotid Catheter for Embolic Capture is a single-use percutaneous catheter system introduced into an artery via guidewire, featuring an embolic capture filter or occlusion balloon at the distal end to capture embolic material during angioplasty and stenting procedures. The device is intended to contain and remove thrombus and debris, protecting against stroke or other cerebrovascular events during carotid interventions. It is an FDA Class 2 device regulated under 21 CFR 870.1250 in the Cardiovascular specialty, with product code NTE, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.

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FEI Numbers

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Basic Information

Product Code: NTE
Device Class: FDA class 2
Regulation Number: 870.1250
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222694	EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)	Apr 27, 2023	Substantially Equivalent	MicroVention, Inc.
K230402	ENROUTE® Transcarotid Neuroprotection System	Apr 11, 2023	Substantially Equivalent	Silk Road Medical
K220654	ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire	Apr 06, 2022	Substantially Equivalent	Cordis Corporation
K210282	WIRION Embolic Protection System	Mar 03, 2021	Substantially Equivalent	Cardiovascular Systems, Inc.
K200198	WIRION	Mar 18, 2020	Substantially Equivalent	Cardiovascular Systems, Inc.
K191173	Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires	Jul 25, 2019	Substantially Equivalent	Abbott Vascular
K180023	WIRION	Mar 21, 2018	Substantially Equivalent	Gardia Medical , Ltd.
K153485	ENROUTE Transcarotid Neuroprotection System	Mar 10, 2016	Substantially Equivalent	Silk Road Medical, Inc.
K153086	RX ACCUNET Embolic Protection System	Nov 20, 2015	Substantially Equivalent	Abbott Vascular
K143570	WIRION	Jun 04, 2015	Substantially Equivalent	Gardia Medical
K143072	ENROUTE Transcarotid Neuroprotection System	Feb 09, 2015	Substantially Equivalent	Silk Road Medical, Inc.
K141678	EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM	Jul 22, 2014	Substantially Equivalent	Abbott Vascular
K123156	GORE FLOW REVERSAL SYSTEM MODEL GFRS073	Dec 13, 2012	Substantially Equivalent	W. L. Gore & Associates, Inc.
K121015	EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM	May 04, 2012	Substantially Equivalent	Abbott Vascular
K120480	GORE(R) EMBOLIC FILTER	Mar 16, 2012	Substantially Equivalent	W.L. Gore & Associates
K111010	SPIDERFX EMBOLIC PROTECTION DEVICE	Oct 27, 2011	Substantially Equivalent	Ev3, Inc.
K111987	FIBERNET EMBOLIC PROTECTION DEVICE	Aug 17, 2011	Substantially Equivalent	Lumen Biomedical, Inc.
K103500	GORE EMBOLIC FILTER	May 23, 2011	Substantially Equivalent	W. L. Gore & Associates, Inc.
K110909	EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..	Apr 29, 2011	Substantially Equivalent	Abbott Laboratories
K101651	ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE	Jul 09, 2010	Substantially Equivalent	Cordis Corp.
K092177	MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6	Oct 15, 2009	Substantially Equivalent	Invatec S.P.A.
K090665	EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19	May 22, 2009	Substantially Equivalent	Abbott Vascular-Vascular Solutions
K083300	GORE FLOW REVERSAL SYSTEM	Feb 04, 2009	Substantially Equivalent	W. L. Gore & Associates, Inc.
K082348	FIBERNET EMBOLIC PROTECTION SYSTEM	Nov 18, 2008	Substantially Equivalent	Lumen Biomedical, Inc.
K081523	EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM	Sep 11, 2008	Substantially Equivalent	Abbott Vascular-Vascular Solutions
K081549	RX ACCUNET LP EMBOLIC PROTECTION SYSTEM	Aug 19, 2008	Substantially Equivalent	Abbott Laboratories
K072990	GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID	Oct 31, 2007	Substantially Equivalent	Medtronic, Inc.
K063313	FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)	Dec 05, 2006	Substantially Equivalent	Boston Scientific Corp
K063204	SPIDERFX EMBOLIC PROTECTION DEVICE	Nov 14, 2006	Substantially Equivalent	Ev3, Inc.
K062531	ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE	Sep 22, 2006	Substantially Equivalent	Cordis Corp., A Johnson & Johnson Co.
K052659	SPIDERX EMBOLIC PROTECTION DEVICE	Feb 17, 2006	Substantially Equivalent	Ev3, Inc.
K052454	THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM	Sep 14, 2005	Substantially Equivalent	Abbott Vascular Devices
K052166	MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM	Aug 18, 2005	Substantially Equivalent	Guidant Corporation
K052165	RX ACCUNET EMBOLIC PROTECTION SYSTEM	Aug 16, 2005	Substantially Equivalent	Guidant Corporation
K042908	RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM	Nov 12, 2004	Substantially Equivalent	Guidant Corp.
K042218	ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM	Aug 31, 2004	Substantially Equivalent	Guidant Corp.