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FDA 510(k)

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

K-Number: K252419 · 2025-08-27

ApplicantAtraverse Medical, Inc.
Decision Date2025-08-27
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is a medical device manufactured by Atraverse Medical, Inc.. It received FDA 510(k) clearance on 2025-08-27 under approval number K252419. 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 (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is a medical device that received FDA 510(k) clearance on 2025-08-27. It is manufactured by Atraverse Medical, Inc.. The 510(k) number is K252419.

When was HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) approved by the FDA?

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) received FDA 510(k) clearance on 2025-08-27, under approval number K252419.

What company makes HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is manufactured by Atraverse Medical, Inc..

What is the FDA product code for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

The FDA product code for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is DXF.

Other Devices by Atraverse Medical, Inc.

K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)

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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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