Cleared Traditional

K844555 - PATHFINDER CARDIOVASCULAR CATHETER

K844555 is the FDA 510(k) clearance for PATHFINDER CARDIOVASCULAR CATHETER by Argon Medical Corp.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K844555 · Argon Medical Corp. · Cardiovascular device
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Mar 1985
Decision
126d
Days
Class 2
Risk

K844555 is an FDA 510(k) clearance for the PATHFINDER CARDIOVASCULAR CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Argon Medical Corp. (Athens, US). The FDA issued a Cleared decision on March 27, 1985 after a review of 126 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 Argon Medical Corp. devices

Submission Details

510(k) Number K844555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date March 27, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
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 293
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K844555.
DIAGNOSTIC INTRAVASCULAR CATHETERS
K853182 · Mallinckrodt Critical Care · Jan 1986
LAP-CATH
K852197 · Research Medical, Inc. · Nov 1985
FAP-CATH
K852456 · Research Medical, Inc. · Nov 1985
LARIAT CATHETER
K844598 · Mallinckrodt Critical Care · Feb 1985
PTCA GUIDING CATHER
K844161 · Cordis Corp. · Jan 1985
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · American Edwards Laboratories · Aug 1984