FDA applicant

Abbott (Formerly Thoratec Corporation)

Pleasanton, CA2 decisions2020–20221 recall

FDA records 2 decisions for Abbott (Formerly Thoratec Corporation) (Pleasanton, CA) from 2020 to 2022: 2 510(k) clearances. Most are in product codes QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use) and DWA (Control, Pump Speed, Cardiopulmonary Bypass). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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 Abbott (Formerly Thoratec Corporation)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2025

2020high 1 (2025) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Abbott (Formerly Thoratec Corporation) by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Abbott”

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

Abbott Laboratories 920 Abbott Medical 92 Abbott Vascular 64 Abbott Diabetes Care, Inc. 42 Abbott Molecular, Inc. 33 Abbott Diagnostics 28 Abbott Point of Care, Inc. 22 Abbott Medical Optics, Inc. 16 Abbott Mfg., Inc. 14 Abbott 14 Abbott Spine, Inc. 13 Abbott Diagnostics Scarborough, Inc. 8

Abbott (Formerly Thoratec Corporation)

Which product codes does it file in?

Whose devices does it build on?

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Other applicant names beginning “Abbott”