Cleared Traditional

K971281 - RAULERSON ONE-STEP GUIDEWIRE INSERTION ...

K971281 is the FDA 510(k) clearance for RAULERSON ONE-STEP GUIDEWIRE INSERTION ... by Medcomp. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K971281 · Medcomp · Cardiovascular device
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Oct 1997
Decision
185d
Days
Class 2
Risk

K971281 is an FDA 510(k) clearance for the RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on October 9, 1997 after a review of 185 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 Medcomp devices

Submission Details

510(k) Number K971281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date October 09, 1997
Days to Decision 185 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 125d · This submission: 185d
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 428
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K971281.
RADIAL AND FEMORAL ARTERY CATHETER
K971086 · B.Braun Medical, Inc. · Dec 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708 · Merit Medical Systems, Inc. · Dec 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG
K973494 · Guidant Corp. · Dec 1997
ACS HI-TORQUE RULER GUIDE WIRE
K972290 · Guidant Corp. · Sep 1997
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
K972142 · Guidant Corp. · Aug 1997
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE
K971395 · Target Therapeutics · Jul 1997