Cleared Traditional

K110643 - MERIT MARQUIS FLOW SWITCH

K110643 is an FDA 510(k) clearance for MERIT MARQUIS FLOW SWITCH, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K110643 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
119d
Days
Class 2
Risk

K110643 is an FDA 510(k) clearance for the MERIT MARQUIS FLOW SWITCH. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Galway, IE). The FDA issued a Cleared decision on July 1, 2011 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K110643

510(k) Number K110643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date July 01, 2011
Days to Decision 119 days
Submission Type Traditional
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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 389
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K110643.
NMI 2.8 MICROCATHETER
K113638 · Navilyst Medical, Inc. · Jan 2012
MICROCATHETER
K112124 · Navilyst Medical, Inc. · Aug 2011
MODIFIED CONCENTRIC MICROCATHETER
K111619 · Concentric Medical, Inc. · Jul 2011
SUREFIRE INFUSION CATHETER SYSTEM
K110459 · Surefire Medical, Inc. · Jun 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
K110103 · Edwards Lifesciences, LLC · Feb 2011
COHEN CROSSOVER CATHETER
K101625 · Vascular Solutions, Inc. · Jul 2010