Cleared Traditional

MONARCH AP(TM) (K943597) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943597 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
202d
Days
Class 2
Risk

K943597 is an FDA 510(k) clearance for the MONARCH AP(TM). Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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

Submission Details

510(k) Number K943597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1994
Decision Date February 10, 1995
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - MAV Syringe, Balloon Inflation

All 56
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K943597.
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773 · Medtronic Vascular · Apr 2022
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038 · Medtronic, Inc. · Apr 2016
Presto Inflation Device
K143522 · C.R. Bard, Inc. · Jan 2015
ENCORE 26 ADVANTAGE KIT
K140745 · Boston Scientific Corp · Apr 2014
ENCORE 26 ADVANTAGE KIT
K123214 · Boston Scientific Corp · Nov 2012
ENCORE 26 ADVANTAGE KIT
K120694 · Boston Scientific Corp · Apr 2012