Cleared Special

K982814 - MEDRAD VISTRON CT INJECTOR SYSTEM

K982814 is the FDA 510(k) clearance for MEDRAD VISTRON CT INJECTOR SYSTEM by Medrad, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Special 510(k) pathway after a 59-day FDA review.

K982814 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Oct 1998
Decision
59d
Days
Class 2
Risk

K982814 is an FDA 510(k) clearance for the MEDRAD VISTRON CT INJECTOR SYSTEM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on October 9, 1998 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medrad, Inc. devices

Submission Details

510(k) Number K982814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1998
Decision Date October 09, 1998
Days to Decision 59 days
Submission Type Special
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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

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 K982814.
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728 · Medrad, Inc. · Nov 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · Medrad, Inc. · Jul 1999
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
K984418 · Medrad, Inc. · Mar 1999
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · Merit Medical Systems, Inc. · Nov 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · Medrad, Inc. · Apr 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · B.Braun Medical, Inc. · Mar 1997