Cleared Traditional

K844555 - PATHFINDER CARDIOVASCULAR CATHETER

K844555 is an FDA 510(k) clearance for PATHFINDER CARDIOVASCULAR CATHETER, manufactured by Argon Medical Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K844555

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
Combination Product No
PCCP Authorized No
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.

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 408
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K844555.
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K844800 · Vas-Cath of Canada , Ltd. · May 1985
UMI ANGIOGRAPHIC CATHETER
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LARIAT CATHETER
K844598 · Mallinckrodt Critical Care · Feb 1985
PTCA GUIDING CATHER
K844161 · Cordis Corp. · Jan 1985
NAMIC ADB ANGIOGRAPHIC DUMP BAG
K843726 · North American Instrument Corp. · Oct 1984