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510(k) K212625

PathBuilder Transseptal Needle by Shanghai Microport EP Medtech Co., Ltd. — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2022
Date Received
August 18, 2021
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

Other clearances by Shanghai Microport EP Medtech Co., Ltd.

  • K210313 — EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (December 30, 2022)
  • K212626 — PathBuilder Transseptal Guiding Introducer (March 23, 2022)
  • K211530 — PathBuilder Steerable Introducer (February 8, 2022)

Other clearances for product code DRC

  • K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230) (July 26, 2024)
  • K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (May 17, 2024)
  • K221707 — SafeSept® Transseptal Guidewire (SS-140) (September 14, 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)