Cleared Traditional

G.E. STERILE ANGIOGRAPHIC TRAY (K960139) - FDA 510(k) Clearance

Class I Cardiovascular device.

K960139 · GE Medical Systems · Cardiovascular device
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Apr 1996
Decision
94d
Days
Class 1
Risk

K960139 is an FDA 510(k) clearance for the G.E. STERILE ANGIOGRAPHIC TRAY. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by GE Medical Systems (Palm Harbor, US). The FDA issued a Cleared decision on April 19, 1996 after a review of 94 days - within the typical 510(k) review window.

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 GE Medical Systems devices

Submission Details

510(k) Number K960139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 16, 1996
Decision Date April 19, 1996
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 14
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K960139.
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G.E. STERILE CT BIOPSY TRAY
K960144 · GE Medical Systems · Apr 1996
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K960143 · GE Medical Systems · Apr 1996
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
K881717 · Buckman Co., Inc. · Jul 1988
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982