Fibernet Embolic Protection System

FDA 510(k) K082348 · Lumen Biomedical, Inc.

Substantially Equivalent

510(k) numberK082348

Submission

Device name
Fibernet Embolic Protection System
Applicant
Lumen Biomedical, Inc.
Plymouth, MN, US
Received
August 15, 2008
Decision date
November 18, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NTE – Temporary Carotid Catheter For Embolic Capture
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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…

Other 510(k)s with product code NTE

510(k)DeviceApplicantDecision
K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional MicroVention, Inc.04/27/2023SE
K230402ENROUTE® Transcarotid Neuroprotection SystemNTE · Special Silk Road Medical04/11/2023SE
K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireNTE · Special Cordis Corporation04/06/2022SE
K210282WIRION Embolic Protection SystemNTE · Special Cardiovascular Systems, Inc.03/03/2021SE
K200198WirionNTE · Traditional Cardiovascular Systems, Inc.03/18/2020SE
K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional Abbott Vascular07/25/2019SE
K180023WirionNTE · Traditional Gardia Medical , Ltd.03/21/2018SE
K153485ENROUTE Transcarotid Neuroprotection SystemNTE · Traditional Silk Road Medical, Inc.03/10/2016SE
K153086RX ACCUNET Embolic Protection SystemNTE · Special Abbott Vascular11/20/2015SE
K143570WirionNTE · Traditional Gardia Medical06/04/2015SE

More from Gardia Medical

510(k)DeviceDecision
K111987Fibernet Embolic Protection DeviceNTE · Special 08/17/2011SE
K080901Lbi Embolectomy SystemQEW · Traditional 10/02/2008SESU
K071529Xtract Catheter SystemQEZ · Special 08/10/2007SE
K053372Lbi Catheter SystemQEZ · Traditional 06/30/2006SE

Questions and answers

When was Fibernet Embolic Protection System cleared by the FDA?

Fibernet Embolic Protection System (K082348) received a 510(k) decision of Substantially Equivalent on November 18, 2008, 95 days after the submission was received.

What is the product code of K082348?

The FDA product code is NTE – Temporary Carotid Catheter For Embolic Capture, a Class II (moderate risk) device regulated under 21 CFR 870.1250.