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FDA 510(k)

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

K-Number: K260292 · 2026-02-27

ApplicantAtraverse Medical
Decision Date2026-02-27
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is the device name listed in this FDA 510(k) record. The listed applicant is Atraverse Medical. It received FDA 510(k) clearance on 2026-02-27 under 510(k) number K260292. 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 2026-02-27. The listed applicant is Atraverse Medical. The 510(k) number is K260292.

When did HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) receive FDA 510(k) clearance?

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) received FDA 510(k) clearance on 2026-02-27, under 510(k) number K260292.

Who is the listed applicant for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

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

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 records listing Atraverse Medical 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.

K252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)K240900HOTWIRE™ RF Guidewire

Related Devices (Code: DXF)

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.

K261745LightningWire Transseptal Puncture System (TPS)ElectroWire MedicalK253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLCK252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse Medical, Inc.K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)Circa Scientific, Inc.K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc.K242076VersaCross™ RF WireBaylis Medical Company

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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