FDA 510(k)

HOTWIRE RF Guidewire

K-Number: K240900 · 2024-05-01

Decision Date2024-05-01

Product CodeDXF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HOTWIRE RF Guidewire is a medical device manufactured by Atraverse Medical. It received FDA 510(k) clearance on 2024-05-01 under approval number K240900. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOTWIRE RF Guidewire?

HOTWIRE RF Guidewire is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Atraverse Medical. The 510(k) number is K240900.

When was HOTWIRE RF Guidewire approved by the FDA?

HOTWIRE RF Guidewire received FDA 510(k) clearance on 2024-05-01, under approval number K240900.

What company makes HOTWIRE RF Guidewire?

HOTWIRE RF Guidewire is manufactured by Atraverse Medical.

What is the FDA product code for HOTWIRE RF Guidewire?

The FDA product code for HOTWIRE RF Guidewire is DXF.

Other Devices by Atraverse Medical

K260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

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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.