Cleared Traditional

DIAGNOSTIC INTRAVASCULAR CATHETER (K923699) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923699 · Applied Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 1992
Decision
150d
Days
Class 2
Risk

K923699 is an FDA 510(k) clearance for the DIAGNOSTIC INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Applied Vascular (Launa Hills, US). The FDA issued a Cleared decision on December 21, 1992 after a review of 150 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Applied Vascular devices

Submission Details

510(k) Number K923699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1992
Decision Date December 21, 1992
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 143
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K923699.
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NYLEX CATHETERS
K930479 · Cordis Corp. · Apr 1993
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K922105 · C.R. Bard, Inc. · Nov 1992
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
K915726 · Baxter Healthcare Corp · Sep 1992
CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER
K921310 · Cordis Corp. · Sep 1992