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510(k) K240246

Accusafe Transseptal Guidewire (GTR31180, GTR31230) by Synaptic Medical Corporation — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2024
Date Received
January 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type

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Other clearances for product code DRC

  • K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (May 17, 2024)
  • K221707 — SafeSept® Transseptal Guidewire (SS-140) (September 14, 2022)
  • K212625 — PathBuilder Transseptal Needle (March 23, 2022)
  • K210328 — SafeSept Blunt Needle (March 5, 2021)
  • 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)
  • K132943 — INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (August 29, 2014)
  • K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (January 8, 2014)