Cleared Traditional

K873173 - MEDRAD MRI INJECTION SYSTEM

K873173 is the FDA 510(k) clearance for MEDRAD MRI INJECTION SYSTEM by Medrad, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K873173 · Medrad, Inc. · Cardiovascular device
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Feb 1988
Decision
177d
Days
Class 2
Risk

K873173 is an FDA 510(k) clearance for the MEDRAD MRI INJECTION SYSTEM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 5, 1988 after a review of 177 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 Medrad, Inc. devices

Submission Details

510(k) Number K873173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1987
Decision Date February 05, 1988
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
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 K873173.
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493 · Medrad, Inc. · Apr 1988
ANGIO DRAPE PACK ACP-010FM
K880310 · Arrow Intl., Inc. · Apr 1988
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · Merit Medical Systems, Inc. · Feb 1988
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · Advanced Cardiovascular Systems, Inc. · Oct 1987
CAVROPUMP
K871129 · Life-Tech Intl., Inc. · Aug 1987
CHIN-FOGARTY INFLATION DEVICE
K863596 · American Edwards Laboratories · Nov 1986