Cleared Traditional

K841926 - HYDROGLIDE SPRING GUIDE WIRES

K841926 is the FDA 510(k) clearance for HYDROGLIDE SPRING GUIDE WIRES by Argon Medical Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K841926 · Argon Medical Corp. · Cardiovascular device
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Jan 1985
Decision
237d
Days
Class 2
Risk

K841926 is an FDA 510(k) clearance for the HYDROGLIDE SPRING GUIDE WIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Argon Medical Corp. (Athens, US). The FDA issued a Cleared decision on January 2, 1985 after a review of 237 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 K841926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1984
Decision Date January 02, 1985
Days to Decision 237 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 125d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 502
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K841926.
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · Advanced Cardiovascular Systems, Inc. · Jun 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · Advanced Cardiovascular Systems, Inc. · Jun 1985
BIOPATCH BOVINE PERICARDIAL PATCH
K840756 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1985
WIREGUIDE OR GUIDEWIRE
K843012 · Medi-Tech, Inc. · Nov 1984
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · Mallinckrodt Critical Care · Feb 1984
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983