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510(k) K251007

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) by Circa Scientific, Inc. — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2025
Date Received
April 1, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Circa Scientific, Inc.

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  • K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, C (September 26, 2024)
  • K240004 — CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable (January 31, 2024)
  • K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System (May 25, 2023)
  • K200943 — Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (December 17, 2021)
  • K112376 — S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM (August 31, 2011)

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)
  • K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (August 27, 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)