Cleared Traditional

K923699 - DIAGNOSTIC INTRAVASCULAR CATHETER

K923699 is an FDA 510(k) clearance for DIAGNOSTIC INTRAVASCULAR CATHETER, manufactured by Applied Vascular. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K923699 · Applied Vascular · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K923699

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.

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 308
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K923699.
RETRIEVER 10
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