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510(k) K212626

PathBuilder Transseptal Guiding Introducer by Shanghai Microport EP Medtech Co., Ltd. — Product Code DYB

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
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
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)
  • K212625 — PathBuilder Transseptal Needle (March 23, 2022)
  • K211530 — PathBuilder Steerable Introducer (February 8, 2022)

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