510(k) K052166

MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM by Guidant Corporation — Product Code NTE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 18, 2005
Date Received: August 9, 2005
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Temporary Carotid Catheter For Embolic Capture
Device Class: Class II
Regulation Number: 870.1250
Review Panel: CV
Submission Type

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

Other clearances by Guidant Corporation

K060449 — HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE (May 30, 2006)
K053459 — OMNILINK .035 BILIARY STENT SYSTEM (April 12, 2006)
K053454 — RX HERCULINK ELITE BILIARY STENT SYSTEM (March 6, 2006)
K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)
K052274 — GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 (September 21, 2005)
K052165 — RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 16, 2005)
K041981 — GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSO (August 20, 2004)
K041762 — FINISHING WIRE SUPPORTRAK (August 6, 2004)
K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (July 12, 2004)

Other clearances for product code NTE

K222694 — EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (April 27, 2023)
K230402 — ENROUTE® Transcarotid Neuroprotection System (April 11, 2023)
K220654 — ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire (April 6, 2022)
K210282 — WIRION Embolic Protection System (March 3, 2021)
K200198 — WIRION (March 18, 2020)
K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (July 25, 2019)
K180023 — WIRION (March 21, 2018)
K153485 — ENROUTE Transcarotid Neuroprotection System (March 10, 2016)
K153086 — RX ACCUNET Embolic Protection System (November 20, 2015)
K143570 — WIRION (June 4, 2015)