Cleared Special

K082034 - MODIFICATION TO MERCI RETRIEVER

K082034 is the FDA 510(k) clearance for MODIFICATION TO MERCI RETRIEVER by Concentric Medical, Inc.. It is a Class 2 Neurology device (product code NRY) cleared through the Special 510(k) pathway after a 29-day FDA review.

K082034 · Concentric Medical, Inc. · Neurology device
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Aug 2008
Decision
29d
Days
Class 2
Risk

K082034 is an FDA 510(k) clearance for the MODIFICATION TO MERCI RETRIEVER. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 15, 2008 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Concentric Medical, Inc. devices

Submission Details

510(k) Number K082034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2008
Decision Date August 15, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
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 Neurology devices follow this clearance model.

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 100
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K082034.
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
K100769 · Penumbra, Inc. · May 2010
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054
K090752 · Penumbra, Inc. · Sep 2009
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
K090085 · Concentric Medical, Inc. · Feb 2009
MERCI RETRIEVER
K081305 · Concentric Medical, Inc. · Jun 2008
PENUMBRA SYSTEM
K072718 · Penumbra, Inc. · Dec 2007
MODIFIED MERCI RETRIEVER, MODEL 90060
K071172 · Concentric Medical, Inc. · Aug 2007