Cleared Special

K040700 - CONCENTRIC RETRIEVER X5, MODEL 90035

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

K040700 is an FDA 510(k) clearance for CONCENTRIC RETRIEVER X5, manufactured by Concentric Medical, Inc.. The device is a Class 2 Cardiovascular device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K040700

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.

DQY Device Classification - Class 2, Special Controls

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 895
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K040700.
VENTURE WIRE CONTROL CATHETER
K040922 · Velocimed, Inc. · Aug 2004
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
K040745 · Concentric Medical, Inc. · Aug 2004
KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
K041151 · Kerberos Proximal Solutions, Inc. · Jul 2004
TRANSXCHANGE SUPPORT CATHETER
K033540 · Medtronic Vascular · May 2004
NUMED MULLINS X PTA CATHETER
K041093 · NuMED, Inc. · May 2004
GORE TRI-LOBE BALLOON CATHETER
K033670 · W.L. Gore & Associates, Inc. · May 2004
K040700 · CONCENTRIC RETRIEVER X5, MODEL 90035
Download PDF FDA Summary Concentric Medical, I…