Cleared Special

K101116 - HI-TORQUE PILOT 50 AND 150 GUIDE WIRE W...

K101116 is the FDA 510(k) clearance for HI-TORQUE PILOT 50 AND 150 GUIDE WIRE W... by Abbott Vascular-Cardiac Therapies. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 63-day FDA review.

K101116 · Abbott Vascular-Cardiac Therapies · Cardiovascular device
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Jun 2010
Decision
63d
Days
Class 2
Risk

K101116 is an FDA 510(k) clearance for the HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Abbott Vascular-Cardiac Therapies (Temecula, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 63 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Vascular-Cardiac Therapies devices

Submission Details

510(k) Number K101116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2010
Decision Date June 23, 2010
Days to Decision 63 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

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 500
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