Cleared Traditional

K080364 - FINDRWIRZ GUIDE WIRE SYSTEM

K080364 is an FDA 510(k) clearance for FINDRWIRZ GUIDE WIRE SYSTEM, manufactured by Sentreheart, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K080364 · Sentreheart, Inc. · Cardiovascular device
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Aug 2008
Decision
182d
Days
Class 2
Risk

K080364 is an FDA 510(k) clearance for the FINDRWIRZ GUIDE WIRE SYSTEM. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Sentreheart, Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 11, 2008 after a review of 182 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 Sentreheart, Inc. devices

FDA 510(k) Submission Details - K080364

510(k) Number K080364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2008
Decision Date August 11, 2008
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
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 594
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K080364.
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K082304 · St Jude Medical · Aug 2008
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
K080637 · Stereotaxis, Inc. · Aug 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021 · Boston Scientific Corp · Aug 2008
APPROACH CTO WIRE GUIDE
K081337 · Cook Incorporated · Aug 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863 · MicroVention, Inc. · Apr 2008