Cleared Traditional

K152497 - PW Guidewires

K152497 is an FDA 510(k) clearance for PW Guidewires, manufactured by Tatara Vascular, LLC. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K152497 · Tatara Vascular, LLC · Cardiovascular device
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Jan 2016
Decision
143d
Days
Class 2
Risk

K152497 is an FDA 510(k) clearance for the PW Guidewires. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Tatara Vascular, LLC (Cleveland, US). The FDA issued a Cleared decision on January 22, 2016 after a review of 143 days - within the typical 510(k) review window.

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 Tatara Vascular, LLC devices

FDA 510(k) Submission Details - K152497

510(k) Number K152497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2015
Decision Date January 22, 2016
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
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 K152497.
ASAHI Fielder XT-A, ASAHI Fielder XT-R
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ASAHI Astato XS 40
K153443 · Asahi Intecc Co., Ltd. · Feb 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · Boston Scientific Corporation · Feb 2016
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
K151840 · Boston Scientific Corporation · Dec 2015
R350 guidewire
K151234 · Vascular Solutions, Inc. · Nov 2015
HI-TORQUE BALANCE
K152709 · Abbott Vascular · Oct 2015