510(k) Report

FDA applicant

MicroPort CRM USA, Inc.

Arlington7 decisions1991–202310 recalls

FDA records 7 decisions for MicroPort CRM USA, Inc. (Arlington) from 1991 to 2023: 7 original PMA approvals. Most are in product codes NVN (Drug Eluting Permanent Right Ventricular (Rv)…) and DXY (Implantable Pacemaker Pulse-Generator). 10 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided MicroPort CRM USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12023: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

6in 2017

2008: 12010: 12017: 6
2007high 6 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — MicroPort CRM USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “MicroPort”

FDA records each applicant name separately; these may or may not be the same firm.