Cleared Traditional

K933846 - ANGIOGRAPHY SYRINGE KITS (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933846 · Angiodynamics, Div. E-Z-Em, Inc. · Cardiovascular device
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Dec 1994
Decision
494d
Days
Class 2
Risk

K933846 is an FDA 510(k) clearance for the ANGIOGRAPHY SYRINGE KITS. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Angiodynamics, Div. E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on December 13, 1994 after a review of 494 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 Angiodynamics, Div. E-Z-Em, Inc. devices

Submission Details

510(k) Number K933846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1993
Decision Date December 13, 1994
Days to Decision 494 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
369d slower than avg
Panel avg: 125d · This submission: 494d
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 206
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K933846.
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