Cleared Traditional

K955689 - RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (FDA 510(k) Clearance)

Class I Cardiovascular device.

K955689 · Contour Fabricators of Florida, Inc. · Cardiovascular device
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May 1996
Decision
153d
Days
Class 1
Risk

K955689 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on May 15, 1996 after a review of 153 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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 Contour Fabricators of Florida, Inc. devices

Submission Details

510(k) Number K955689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date May 15, 1996
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 125d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.