Cleared Special

K040700 - CONCENTRIC RETRIEVER X5

Also marketed or referenced as:
CONCENTRIC RETRIEVER X6, MODEL 90037

K040700 is the FDA 510(k) clearance for CONCENTRIC RETRIEVER X5 by Concentric Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 96-day FDA review.

K040700 · Concentric Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
96d
Days
Class 2
Risk

K040700 is an FDA 510(k) clearance for the CONCENTRIC RETRIEVER X5, MODEL 90035. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 21, 2004 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Standard predicate reliance. 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 K040700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date June 21, 2004
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K040700.
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K042194 · Medtronic Vascular · Sep 2004
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
K040745 · Concentric Medical, Inc. · Aug 2004
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K033670 · W.L. Gore & Associates, Inc. · May 2004