Fibernet Embolic Protection Device

FDA 510(k) K111987 · Lumen Biomedical, Inc.

Substantially Equivalent

510(k) numberK111987

Submission

Device name
Fibernet Embolic Protection Device
Applicant
Lumen Biomedical, Inc.
Maple Grove, MN, US
Received
July 13, 2011
Decision date
August 17, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 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
K082348Fibernet Embolic Protection SystemNTE · Traditional 11/18/2008SE
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 Device cleared by the FDA?

Fibernet Embolic Protection Device (K111987) received a 510(k) decision of Substantially Equivalent on August 17, 2011, 35 days after the submission was received.

What is the product code of K111987?

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