Cleared Special

K121051 - CONCIERGE GUIDING CATHETER

K121051 is an FDA 510(k) clearance for CONCIERGE GUIDING CATHETER, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 68-day FDA review.

K121051 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
68d
Days
Class 2
Risk

K121051 is an FDA 510(k) clearance for the CONCIERGE GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Angleton, US). The FDA issued a Cleared decision on June 13, 2012 after a review of 68 days - a notably fast clearance cycle.

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. 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 - K121051

510(k) Number K121051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2012
Decision Date June 13, 2012
Days to Decision 68 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
57d faster than avg
Panel avg: 125d · This submission: 68d
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 878
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K121051.
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
K120781 · Fuji Systems Corp. · Aug 2012
CONVEY GUIDING CATHETER
K120585 · Pendracare International, B.V. · Aug 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K121839 · LeMaitre Vascular, Inc. · Aug 2012
UPSTREAM GR CATHETER
K120964 · Upstream Peripheral Technologies · May 2012
SWITCH-IT CATHETER
K120707 · Vascular Solutions, Inc. · May 2012
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
K120296 · St. Jude Medical, Cardiac Rhythm Management Divisi · May 2012
K121051 · CONCIERGE GUIDING CATHETER
Download PDF FDA Summary Merit Medical Systems…