FDA 510(k)

HI-TORQUE InfilTrac Guide Wire Family

K-Number: K193126 · 2019-12-11

Decision Date2019-12-11

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HI-TORQUE InfilTrac Guide Wire Family is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K193126. 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 InfilTrac Guide Wire Family?

HI-TORQUE InfilTrac Guide Wire Family is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Abbott Vascular. The 510(k) number is K193126.

When did HI-TORQUE InfilTrac Guide Wire Family receive FDA 510(k) clearance?

HI-TORQUE InfilTrac Guide Wire Family received FDA 510(k) clearance on 2019-12-11, under 510(k) number K193126.

Who is the listed applicant for HI-TORQUE InfilTrac Guide Wire Family?

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

What is the FDA product code for HI-TORQUE InfilTrac Guide Wire Family?

The FDA product code for HI-TORQUE InfilTrac Guide Wire Family is DQX.

Other records listing Abbott Vascular as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P110019Coronary drug-eluting stent PMA P960043Device, hemostasis, vascular PMA P040038Stent, carotid PMA P110028STENT, ILIAC PMA P110001STENT, RENAL PMA P040012Stent, carotid

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Related Devices (Code: DQX)

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Official Source

View on FDA Database →

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