Cleared Traditional

K934086 - MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE

K934086 is an FDA 510(k) clearance for MEDRAD ENVISION CT INJECTOR AND QWIK FI..., manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 660-day FDA review.

K934086 · Medrad, Inc. · Cardiovascular device
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Jun 1995
Decision
660d
Days
Class 2
Risk

K934086 is an FDA 510(k) clearance for the MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE. 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 June 15, 1995 after a review of 660 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Medrad, Inc. devices

FDA 510(k) Submission Details - K934086

510(k) Number K934086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1993
Decision Date June 15, 1995
Days to Decision 660 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
535d slower than avg
Panel avg: 125d · This submission: 660d
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 169
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K934086.
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
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SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
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MEDRAD CT CUSTOM CONVENIENCE KIT
K933908 · Medrad, Inc. · Feb 1994
CAVERNOSOMETRY MODULE FOR MENUET
K923117 · Dantec Medical, Inc. · Feb 1993
MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
K924116 · Medrad, Inc. · Jan 1993