Cleared Traditional

K921148 - CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE

K921148 is an FDA 510(k) clearance for CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE, manufactured by Cardiovascular Imaging Systems, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K921148 · Cardiovascular Imaging Systems, Inc. · Radiology device
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Jun 1992
Decision
97d
Days
Class 2
Risk

K921148 is an FDA 510(k) clearance for the CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Cardiovascular Imaging Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 16, 1992 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovascular Imaging Systems, Inc. devices

FDA 510(k) Submission Details - K921148

510(k) Number K921148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1992
Decision Date June 16, 1992
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 239
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K921148.
CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM
K921563 · Cardio Metrics, Inc. · Jul 1992
ACUSON C366 TRANSDUCER
K911916 · Acuson Corp. · Jun 1992
CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE
K921147 · Cardiovascular Imaging Systems, Inc. · Jun 1992
SONOS 100 ULTRASOUND IMAGING SYSTEM
K921036 · Hewlett-Packard Co. · May 1992
AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION
K920307 · Ausonics Pty , Ltd. · May 1992
SACA, 3.5 MHZ PROBE
K905200 · Diasonics, Inc. · Apr 1992