Cleared Traditional

K943597 - MONARCH AP(TM)

K943597 is an FDA 510(k) clearance for MONARCH AP(TM), manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 202-day FDA review.

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

FDA 510(k) Submission Details - K943597

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
Combination Product No
PCCP Authorized No
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.

MAV Device Classification - Class 2, Special Controls

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 45
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K943597.
BREEZE DIGITAL INFLATION DEVICE
K953676 · Namic · Mar 1996
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · Scimed Life Systems, Inc. · Mar 1996
OSCILFLATOR
K952566 · Surgical Technologies, Inc. · Aug 1995
MEDTRONIC EVEREST INFLATION DEVICE
K942269 · Medtronics Interventional Vascular · Oct 1994
MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
K940896 · Medex, Inc. · Aug 1994
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
K940425 · Imagyn Medical, Inc. · Aug 1994