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510(k) K252419

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) by Atraverse Medical, Inc. — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2025
Date Received
August 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Septostomy
Device Class
Class II
Regulation Number
870.5175
Review Panel
CV
Submission Type

Other clearances by Atraverse Medical, Inc.

  • K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (February 27, 2026)
  • K252083 — HOTWIRE™ System RF Generator and Footswitch (optional accessory) (August 12, 2025)
  • K240900 — HOTWIRE™ RF Guidewire (May 1, 2024)

Other clearances for product code DXF

  • K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135 (March 13, 2026)
  • K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (February 27, 2026)
  • K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW (May 1, 2025)
  • K243193 — Cross Wise™ Multi-Use RF Adapter Cable (November 26, 2024)
  • K242076 — VersaCross™ RF Wire (November 1, 2024)
  • K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, C (September 26, 2024)
  • K240900 — HOTWIRE™ RF Guidewire (May 1, 2024)
  • K232852 — Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (October 12, 2023)
  • K221528 — Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Cathet (August 22, 2022)
  • K211910 — Z-6 Atrioseptostomy Catheter (July 19, 2021)