Cleared Traditional

K924922 - CVIS INSIGHT IMAGING CATHETER

K924922 is an FDA 510(k) clearance for CVIS INSIGHT IMAGING CATHETER, manufactured by Cardiovascular Imaging Systems, Inc.. The device is a Class 2 Radiology device with product code DQO cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K924922 · Cardiovascular Imaging Systems, Inc. · Radiology device
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Jun 1993
Decision
330d
Days
Class 2
Risk

K924922 is an FDA 510(k) clearance for the CVIS INSIGHT IMAGING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cardiovascular Imaging Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 29, 1993 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1200 - 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. Elevated predicate reliance profile. 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 - K924922

510(k) Number K924922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1992
Decision Date June 29, 1993
Days to Decision 330 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
223d slower than avg
Panel avg: 107d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 347
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K924922.
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542 · Scimed Life Systems, Inc. · Aug 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · C.R. Bard, Inc. · Jul 1993
CVIS INSIGHT IMAGING GUIDE CATHETER
K930232 · Cardiovascular Imaging Systems, Inc. · Jul 1993
BALT GUIDING CATHETER
K925632 · Target Therapeutics · Jun 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891 · Cordis Corp. · Jun 1993
SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER
K926003 · Schneider Intl., Ltd. · Jun 1993