Cleared Traditional

K930232 - CVIS INSIGHT IMAGING GUIDE CATHETER

K930232 is an FDA 510(k) clearance for CVIS INSIGHT IMAGING GUIDE 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 183-day FDA review.

K930232 · Cardiovascular Imaging Systems, Inc. · Radiology device
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Jul 1993
Decision
183d
Days
Class 2
Risk

K930232 is an FDA 510(k) clearance for the CVIS INSIGHT IMAGING GUIDE 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 July 21, 1993 after a review of 183 days - an extended review cycle.

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. 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 - K930232

510(k) Number K930232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date July 21, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 107d · This submission: 183d
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 K930232.
ANGIOGRAPHIC CATHETER
K926243 · Target Therapeutics · Aug 1993
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542 · Scimed Life Systems, Inc. · Aug 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · C.R. Bard, Inc. · Jul 1993
CVIS INSIGHT IMAGING CATHETER
K924922 · Cardiovascular Imaging Systems, Inc. · Jun 1993
BALT GUIDING CATHETER
K925632 · Target Therapeutics · Jun 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891 · Cordis Corp. · Jun 1993