Cleared Traditional

K883202 - ULTRASONIC IMAGING CATHETER

K883202 is the FDA 510(k) clearance for ULTRASONIC IMAGING CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K883202 · Boston Scientific Corp · Cardiovascular device
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Nov 1988
Decision
118d
Days
Class 2
Risk

K883202 is an FDA 510(k) clearance for the ULTRASONIC IMAGING CATHETER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on November 23, 1988 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 Boston Scientific Corp devices

Submission Details

510(k) Number K883202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date November 23, 1988
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 24
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K883202.
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
K053016 · Edwards Lifesciences, LLC · Dec 2005
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · Baxter Healthcare Corp · Oct 1993
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · Baxter Healthcare Corp · Jul 1991
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · Draeger Medical, Inc. · Jul 1988
VSM R1
K842213 · Physio-Control Corp. · Oct 1984