Cleared Traditional

K883888 - CATHSCANNER INTRAVASCULAR ULTRASONIC IM...

K883888 is an FDA 510(k) clearance for CATHSCANNER INTRAVASCULAR ULTRASONIC IM..., manufactured by Advanced Biosearch Assn.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K883888 · Advanced Biosearch Assn. · Cardiovascular device
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Dec 1988
Decision
88d
Days
Class 2
Risk

K883888 is an FDA 510(k) clearance for the CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Advanced Biosearch Assn. (Danville, US). The FDA issued a Cleared decision on December 12, 1988 after a review of 88 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 Advanced Biosearch Assn. devices

FDA 510(k) Submission Details - K883888

510(k) Number K883888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date December 12, 1988
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DXK Echocardiograph

All 42
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K883888.
ULTRAMARK 7 ULTRASOUND SYSTEM
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EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
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RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555 · General Electric Co. · Mar 1988