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510(k) K253799

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) by Pressure Products Medical Device Manufacturing, LLC — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2026
Date Received
November 28, 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 Pressure Products Medical Device Manufacturing, LLC

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  • K181031 — TSI Transseptal Introducer (October 26, 2018)
  • K172950 — TSN Transseptal Needle (February 21, 2018)
  • K172934 — Needle Free Transseptal Cannula (February 16, 2018)
  • K172893 — SafeSept Needle Free Transseptal Guidewire (December 21, 2017)
  • K170671 — SafeSept Transseptal Guidewire (October 20, 2017)

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  • 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)