Cleared Traditional

K080901 - LBI EMBOLECTOMY SYSTEM

K080901 is an FDA 510(k) clearance for LBI EMBOLECTOMY SYSTEM, manufactured by Lumen Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K080901 · Lumen Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
185d
Days
Class 2
Risk

K080901 is an FDA 510(k) clearance for the LBI EMBOLECTOMY SYSTEM. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Lumen Biomedical, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 2, 2008 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080901

510(k) Number K080901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 31, 2008
Decision Date October 02, 2008
Days to Decision 185 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 144
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K080901.
F.A.S.T. SYSTEM SED AND CXD
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NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000
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D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
K083370 · Artegraft, Inc. · Dec 2008
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060
K041374 · Idev Technologies, Inc. · Mar 2005
GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS
K040010 · Genesis Medical Interventional, Inc. · Jul 2004
XTD THROMBECTOMY CATHETER, XX CM
K021641 · Xtrak Medical, Inc. · Jul 2002
K080901 · LBI EMBOLECTOMY SYSTEM
Download PDF FDA Summary Lumen Biomedical, Inc.