Cleared Special

K090085 - MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113

K090085 is an FDA 510(k) clearance for MERCI RETRIEVER, manufactured by Concentric Medical, Inc.. The device is a Class 2 Neurology device with product code NRY cleared through the Special 510(k) pathway after a 30-day FDA review.

K090085 · Concentric Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
30d
Days
Class 2
Risk

K090085 is an FDA 510(k) clearance for the MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113. 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 February 12, 2009 after a review of 30 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.

FDA 510(k) Submission Details - K090085

510(k) Number K090085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2009
Decision Date February 12, 2009
Days to Decision 30 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: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NRY Device Classification - Class 2, Special Controls

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 116
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K090085.
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
K093610 · Concentric Medical, Inc. · Feb 2011
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
MODIFICATION TO MERCI RETRIEVER
K082034 · Concentric Medical, Inc. · Aug 2008
MERCI RETRIEVER
K081305 · Concentric Medical, Inc. · Jun 2008
PENUMBRA SYSTEM
K072718 · Penumbra, Inc. · Dec 2007
K090085 · MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
Download PDF FDA Summary Concentric Medical, I…