FDA 510(k)

HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

K-Number: K101116 · 2010-06-23

ApplicantAbbott Vascular-Cardiac Therapies

Decision Date2010-06-23

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular-Cardiac Therapies. It received FDA 510(k) clearance on 2010-06-23 under 510(k) number K101116. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH?

HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is Abbott Vascular-Cardiac Therapies. The 510(k) number is K101116.

When did HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH receive FDA 510(k) clearance?

HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH received FDA 510(k) clearance on 2010-06-23, under 510(k) number K101116.

Who is the listed applicant for HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH?

The FDA 510(k) record lists Abbott Vascular-Cardiac Therapies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH?

The FDA product code for HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH is DQX.

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Other records listing Abbott Vascular-Cardiac Therapies as applicant

K112957HI-TORQUE POWERTURN K110134NC TREK RX CORONARY DILATATION CATHETER K103101HI-TORQUE BALANCE MIDDLEWEIGHT ELITE K103110MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER K103153VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER

Related Devices (Code: DQX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.