Cleared Special

K993728 - MEDRAD ENVISION CT INJECTOR SYSTEM

K993728 is an FDA 510(k) clearance for MEDRAD ENVISION CT INJECTOR SYSTEM, manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Special 510(k) pathway after a 22-day FDA review.

K993728 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
22d
Days
Class 2
Risk

K993728 is an FDA 510(k) clearance for the MEDRAD ENVISION 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 November 26, 1999 after a review of 22 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.

FDA 510(k) Submission Details - K993728

510(k) Number K993728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1999
Decision Date November 26, 1999
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 210
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K993728.
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826 · Unimachs Corp. · Mar 2000
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
K993774 · Acist Medical Systems · Dec 1999
OPTISTAR MR INJECTOR SYSTEM
K984088 · Mallinckrodt Inc., Liebel-Flarsheim Business · Dec 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · Medrad, Inc. · Jul 1999
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
K984418 · Medrad, Inc. · Mar 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K982814 · Medrad, Inc. · Oct 1998
K993728 · MEDRAD ENVISION CT INJECTOR SYSTEM
Download PDF FDA Summary Medrad, Inc.