Cleared Traditional

K090932 - NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000

Also marketed or referenced as:
80 CM, MODEL MRD-2000

K090932 is an FDA 510(k) clearance for NEXGEN PERIPHERAL MECHANICAL RETRIEVAL ..., manufactured by Nexgen Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K090932 · Nexgen Medical Systems, Inc. · Cardiovascular device
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Sep 2009
Decision
175d
Days
Class 2
Risk

K090932 is an FDA 510(k) clearance for the NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Nexgen Medical Systems, Inc. (Reno, US). The FDA issued a Cleared decision on September 24, 2009 after a review of 175 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 - K090932

510(k) Number K090932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2009
Decision Date September 24, 2009
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
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 K090932.
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K080901 · Lumen Biomedical, Inc. · Oct 2008
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060
K041374 · Idev Technologies, Inc. · Mar 2005
K090932 · NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000
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