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

FDA 510(k) K252419 · Atraverse Medical, Inc.

Substantially Equivalent

510(k) numberK252419

Submission

Device name
Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)
Applicant
Atraverse Medical, Inc.
Cardiff By The Sea, CA, US
Received
August 1, 2025
Decision date
August 27, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

510(k)DeviceApplicantDecision
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
K260292Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Special Atraverse Medical02/27/2026SE
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
K260292Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Special 02/27/2026SE
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) (K252419) received a 510(k) decision of Substantially Equivalent on August 27, 2025, 26 days after the submission was received.

What is the product code of K252419?

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