Cleared Traditional

K973230 - MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)

K973230 is an FDA 510(k) clearance for MONARCH (IN 2125)/INTELLISYSTEM (IN 1125), manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973230 · Merit Medical Systems, Inc. · Cardiovascular device
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Nov 1997
Decision
90d
Days
Class 2
Risk

K973230 is an FDA 510(k) clearance for the MONARCH (IN 2125)/INTELLISYSTEM (IN 1125). Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 25, 1997 after a review of 90 days - within the typical 510(k) review window.

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 - K973230

510(k) Number K973230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1997
Decision Date November 25, 1997
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
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 - DXT Injector And Syringe, Angiographic

All 162
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K973230.
MEDRAD VISTRON CT INJECTOR SYSTEM
K982814 · Medrad, Inc. · Oct 1998
OZ POWER SYRINGE
K973334 · Cardiovascular Innovations · Apr 1998
ACIST ANGIOGRAPHIC INJECTOR
K963982 · Invasatec · Dec 1997
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712 · Coeur Laboratories, Inc. · Oct 1997
ANGIOMAT ILLUMENA
K963071 · Mallinckrodt Inc., Liebel-Flarsheim Business · Sep 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · Medrad, Inc. · Apr 1997