PathBuilder Transseptal Needle— 510(k) K212625

Name: FDA 510(k) clearance K212625
Creator: U.S. Food and Drug Administration
Published: 2022-03-23

Substantially Equivalent

Shanghai Microport EP Medtech Co., Ltd.

FDA 510(k) clearance K212625 for PathBuilder Transseptal Needle, Substantially Equivalent on 2022-03-23. Applicant: Shanghai Microport EP Medtech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Microport EP Medtech Co., Ltd.
Product code: Code DRC
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Date received: 2021-08-18
Decision date: 2022-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230)2024-07-26
K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)2024-05-17
K221707 — SafeSept® Transseptal Guidewire (SS-140)2022-09-14
K210328 — SafeSept Blunt Needle2021-03-05
K172950 — TSN Transseptal Needle2018-02-21

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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.