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FDA 510(k)

CrossTorq 14 Guidewire

K-Number: K193194 · 2019-12-13

ApplicantScientia Cardio Access, LLC
Decision Date2019-12-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CrossTorq 14 Guidewire is a medical device manufactured by Scientia Cardio Access, LLC. It received FDA 510(k) clearance on 2019-12-13 under approval number K193194. 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 CrossTorq 14 Guidewire?

CrossTorq 14 Guidewire is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Scientia Cardio Access, LLC. The 510(k) number is K193194.

When was CrossTorq 14 Guidewire approved by the FDA?

CrossTorq 14 Guidewire received FDA 510(k) clearance on 2019-12-13, under approval number K193194.

What company makes CrossTorq 14 Guidewire?

CrossTorq 14 Guidewire is manufactured by Scientia Cardio Access, LLC.

What is the FDA product code for CrossTorq 14 Guidewire?

The FDA product code for CrossTorq 14 Guidewire is 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.

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