Cleared Traditional

K170684 - Firebow Wire Torque Assist Device

K170684 is the FDA 510(k) clearance for Firebow Wire Torque Assist Device by Vesatek, LLC. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K170684 · Vesatek, LLC · Cardiovascular device
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Jun 2017
Decision
114d
Days
Class 2
Risk

K170684 is an FDA 510(k) clearance for the Firebow Wire Torque Assist Device. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Vesatek, LLC (Irvine, US). The FDA issued a Cleared decision on June 29, 2017 after a review of 114 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 Vesatek, LLC devices

Submission Details

510(k) Number K170684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2017
Decision Date June 29, 2017
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
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 502
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K170684.
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