Cleared Traditional

K884913 - MERIT INTELLIFLATOR(TM) & MERIT MONITOR...

K884913 is the FDA 510(k) clearance for MERIT INTELLIFLATOR(TM) & MERIT MONITOR... by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K884913 · Merit Medical Systems, Inc. · Cardiovascular device
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Apr 1989
Decision
141d
Days
Class 2
Risk

K884913 is an FDA 510(k) clearance for the MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM). Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 18, 1989 after a review of 141 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

Submission Details

510(k) Number K884913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date April 18, 1989
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K884913.
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415 · C.R. Bard, Inc. · Jan 1990
HIGH PRESSURE CONNECTING SETS
K890208 · E-Z-Em, Inc. · May 1989
ACS INDEFLATOR P/T 20
K883452 · Advanced Cardiovascular Systems, Inc. · Oct 1988
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493 · Medrad, Inc. · Apr 1988
ANGIO DRAPE PACK ACP-010FM
K880310 · Arrow Intl., Inc. · Apr 1988