FDA applicant

Thoratec Corp

Pleasanton, CA4 decisions1994–20153 recalls

FDA records 4 decisions for Thoratec Corp (Pleasanton, CA) from 1994 to 2015: 3 510(k) clearances and 1 original PMA approval. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DSQ (Ventricular (Assist) Bypass). Its devices cite 4 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Thoratec Corporation”.

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 Thoratec Corp’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Thoratec Corp’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 Laboratories Corp. 11 Thoratec Corporation (Now Part of Abbott) 1

Thoratec Corp

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Thoratec”