FDA applicant

Thoratec Laboratories Corp.

Walker, MI11 decisions1978–20003 recalls

FDA records 11 decisions for Thoratec Laboratories Corp. (Walker, MI) from 1978 to 2000: 10 510(k) clearances and 1 original PMA approval. Most are in product codes DSQ (Ventricular (Assist) Bypass) and DYB (Introducer, Catheter). 3 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, anesthesiology panel, where it files most

How often FDA has decided Thoratec Laboratories Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thoratec Laboratories Corp. since 2007.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Thoratec Laboratories 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 “Thoratec”

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

Thoratec Corp 4 Thoratec Corporation (Now Part of Abbott) 1

Thoratec Laboratories Corp.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Thoratec”