Cleared Traditional

K911384 - CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (FDA 510(k) Clearance)

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

K911384 · Endosonics Corp. · Cardiovascular device
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Jun 1991
Decision
89d
Days
Class 2
Risk

K911384 is an FDA 510(k) clearance for the CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Endosonics Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on June 25, 1991 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Endosonics Corp. devices

Submission Details

510(k) Number K911384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date June 25, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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.