Cleared Traditional

K050456 - MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM

K050456 is an FDA 510(k) clearance for MEDRAD AVANTA FLUID MANAGEMENT INJECTIO..., 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 114-day FDA review.

K050456 · Medrad, Inc. · Cardiovascular device
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Jun 2005
Decision
114d
Days
Class 2
Risk

K050456 is an FDA 510(k) clearance for the MEDRAD AVANTA FLUID MANAGEMENT INJECTION 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 June 17, 2005 after a review of 114 days - within the typical 510(k) review window.

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 Medrad, Inc. devices

FDA 510(k) Submission Details - K050456

510(k) Number K050456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2005
Decision Date June 17, 2005
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
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 168
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