Cleared Special

K072796 - MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044

K072796 is an FDA 510(k) clearance for MEERCI RETRIEVER, manufactured by Concentric Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 78-day FDA review.

K072796 · Concentric Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
78d
Days
Class 2
Risk

K072796 is an FDA 510(k) clearance for the MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066.... Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 18, 2007 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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 - K072796

510(k) Number K072796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date December 18, 2007
Days to Decision 78 days
Submission Type Special
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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 498
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K072796.
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736 · Terumo Medical Corp. · Sep 2008
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
K073585 · Vascular Solutions, Inc. · Apr 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
K073200 · Vascular Solutions, Inc. · Feb 2008
MICRUS COURIER ENZO MICROCATHETER 0.0190
K072526 · Micrus Endovascular Corporation · Oct 2007
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
K071196 · Coeur, Inc. · Sep 2007
MICRUS COURIER ENZO MICROCATHETER 0.017
K070456 · Micrus Endovascular Corporation · May 2007
K072796 · MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
Download PDF FDA Summary Concentric Medical, I…