Cleared Traditional

K883202 - ULTRASONIC IMAGING CATHETER

K883202 is an FDA 510(k) clearance for ULTRASONIC IMAGING CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K883202

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.

DXO Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K883202.
MILLAR MIKRO-TIP PULSE TRANSDUCER
K895721 · Millar Instruments, Inc. · Dec 1989
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K894033 · Deseret Medical, Inc. · Oct 1989
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K894286 · Ppg Industries, Inc. · Oct 1989
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K883436 · Ppg Industries, Inc. · Oct 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · Draeger Medical, Inc. · Jul 1988