Cleared Traditional

K971281 - RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE

K971281 is an FDA 510(k) clearance for RAULERSON ONE-STEP GUIDEWIRE INSERTION ..., manufactured by Medcomp. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K971281

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
Combination Product No
PCCP Authorized No
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.

DQX Device Classification - Class 2, Special Controls

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 622
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K971281.
THEROX INFUSION GUIDEWIRES
K971719 · Therox, Inc. · Nov 1997
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
K972944 · Medtronics Interventional Vascular · Nov 1997
CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
K972762 · Cardio Metrics, Inc. · Oct 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
CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
K965140 · Cardio Metrics, Inc. · Aug 1997