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510(k) K211530

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2022
Date Received
May 17, 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.

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  • K212626 — PathBuilder Transseptal Guiding Introducer (March 23, 2022)

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