Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)

FDA 510(k) K260292 · Atraverse Medical

Substantially Equivalent

510(k) numberK260292

Submission

Device name
Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)
Applicant
Atraverse Medical
Cardiff By The Sea, CA, US
Received
January 29, 2026
Decision date
February 27, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
DXF – Catheter, Septostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5175
Specialty
Cardiovascular

Other 510(k)s with product code DXF

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K261745LightningWire Transseptal Puncture System (TPS)DXF · Traditional ElectroWire Medical06/26/2026SE
K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…DXF · Special Pressure Products Medical Device Manufacturing…03/13/2026SE
K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Traditional Atraverse Medical, Inc.08/27/2025SE
K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C…DXF · Special Circa Scientific, Inc.05/01/2025SE
K243193Cross Wise™ Multi-Use RF Adapter CableDXF · Special Circa Scientific, Inc.11/26/2024SE
K242076VersaCross™ RF WireDXF · Special Baylis Medical Company11/01/2024SE
K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…DXF · Traditional Circa Scientific, Inc.09/26/2024SE
K240900HOTWIRE™ RF GuidewireDXF · Traditional Atraverse Medical05/01/2024SE
K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableDXF · Traditional Cross Vascular, Inc.10/12/2023SE
K221528Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy CatheterDXF · Traditional Edwards Lifesciences, LLC08/22/2022SE

More from Edwards Lifesciences, LLC

510(k)DeviceDecision
K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Traditional 08/27/2025SE
K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)GEI · Traditional 08/12/2025SE
K240900HOTWIRE™ RF GuidewireDXF · Traditional 05/01/2024SE

Questions and answers

When was Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) cleared by the FDA?

Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) (K260292) received a 510(k) decision of Substantially Equivalent on February 27, 2026, 29 days after the submission was received.

What is the product code of K260292?

The FDA product code is DXF – Catheter, Septostomy, a Class II (moderate risk) device regulated under 21 CFR 870.5175.