Cleared Traditional

K972762 - CARDIOMETRICS FLOWIRE 300 AND XT 300 DO...

K972762 is an FDA 510(k) clearance for CARDIOMETRICS FLOWIRE 300 AND XT 300 DO..., manufactured by Cardio Metrics, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K972762 · Cardio Metrics, Inc. · Cardiovascular device
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Oct 1997
Decision
82d
Days
Class 2
Risk

K972762 is an FDA 510(k) clearance for the CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cardio Metrics, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 14, 1997 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardio Metrics, Inc. devices

FDA 510(k) Submission Details - K972762

510(k) Number K972762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1997
Decision Date October 14, 1997
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K972762.
RADIAL AND FEMORAL ARTERY CATHETER
K971086 · B.Braun Medical, Inc. · Dec 1997
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
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K973494 · Guidant Corp. · Dec 1997
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
K971281 · Medcomp · 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