Cleared Traditional

K944844 - BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT (FDA 510(k) Clearance)

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

K944844 · Baxter Healthcare Corp · Cardiovascular device
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Mar 1995
Decision
182d
Days
Class 2
Risk

K944844 is an FDA 510(k) clearance for the BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 182 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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.

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Submission Details

510(k) Number K944844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received September 30, 1994
Decision Date March 31, 1995
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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.