Cleared Traditional

K833645 - CONTRAST MEDIA INJECT. SET CMS

K833645 is an FDA 510(k) clearance for CONTRAST MEDIA INJECT. SET CMS, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K833645 · Gish Biomedical, Inc. · Cardiovascular device
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Apr 1984
Decision
183d
Days
Class 2
Risk

K833645 is an FDA 510(k) clearance for the CONTRAST MEDIA INJECT. SET CMS. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 183 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K833645

510(k) Number K833645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date April 17, 1984
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
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 110
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K833645.
ACS INDEFLATOR (MODIFICATION)
K854310 · Advanced Cardiovascular Systems, Inc. · Dec 1985
LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE
K851402 · Medi-Tech, Inc. · Jun 1985
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045 · Advanced Cardiovascular Systems, Inc. · Nov 1984
ANGIOGRAPHIC DRAPE PACKS
K840281 · Medrad, Inc. · Apr 1984
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107 · Cordis Corp. · Jan 1984
DIGITAL INJECTOR SYS
K833138 · Sybron Corp. · Nov 1983