NTE — Temporary Carotid Catheter For Embolic Capture

21 CFR 870.1250

Class 2

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

Medical Specialty

CV

Review Panel

CV

Submission Type

1

FDA Authorisations (36)

Device Name K-Number
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) K222694
ENROUTE® Transcarotid Neuroprotection System K230402
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire K220654
WIRION Embolic Protection System K210282
WIRION K200198
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires K191173
WIRION K180023
ENROUTE Transcarotid Neuroprotection System K153485
RX ACCUNET Embolic Protection System K153086
WIRION K143570
ENROUTE Transcarotid Neuroprotection System K143072
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM K141678
GORE FLOW REVERSAL SYSTEM MODEL GFRS073 K123156
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM K121015
GORE(R) EMBOLIC FILTER K120480
SPIDERFX EMBOLIC PROTECTION DEVICE K111010
FIBERNET EMBOLIC PROTECTION DEVICE K111987
GORE EMBOLIC FILTER K103500
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. K110909
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE K101651
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