510(k) Report

FDA applicant

Corcym Canada Corp

Burnaby2 decisions2007–20140 recalls

FDA records 2 decisions for Corcym Canada Corp (Burnaby) from 2007 to 2014: 2 original PMA approvals. All are in product code LWR (Heart-Valve, Non-Allograft Tissue). No recall is 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 Corcym Canada Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Corcym Canada Corp by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Corcym”

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