Cleared Traditional

K823064 - INTRACATH-DA INTRAVENOUS CATH. PLACEMENT

K823064 is the FDA 510(k) clearance for INTRACATH-DA INTRAVENOUS CATH. PLACEMENT by Parke-Davis Co.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K823064 · Parke-Davis Co. · Cardiovascular device
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Jan 1983
Decision
101d
Days
Class 2
Risk

K823064 is an FDA 510(k) clearance for the INTRACATH-DA INTRAVENOUS CATH. PLACEMENT. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Parke-Davis Co. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1983 after a review of 101 days - within the typical 510(k) review window.

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 Parke-Davis Co. devices

Submission Details

510(k) Number K823064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1982
Decision Date January 27, 1983
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
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 237
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K823064.
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415 · Mallinckrodt Critical Care · Apr 1983
FORGARTY BALLOON CALIBRATOR
K830734 · American Edwards Laboratories · Apr 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · C.R. Bard, Inc. · Mar 1983
SIDEARM Y-ADAPTOR
K823243 · American Edwards Laboratories · Jan 1983
BRACHIAL CORONARY GUIDING CATHETER
K822862 · Advanced Cardiovascular Systems, Inc. · Oct 1982
CORONARY INFUSION KIT
K822640 · Mallinckrodt Critical Care · Sep 1982