510(k) Report

FDA applicant

St. Jude Medical (Now Part of Abbott Medical)

St. Paul, MN1 decision2018–20180 recalls

FDA records 1 decision for St. Jude Medical (Now Part of Abbott Medical) (St. Paul, MN) in 2018: 1 510(k) clearance. All are in product code DXO (Transducer, Pressure, Catheter Tip). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 St. Jude Medical (Now Part of Abbott Medical)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — St. Jude Medical (Now Part of Abbott Medical) by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXOTransducer, Pressure, Catheter Tip1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical) · 2018

The one decision as St. Jude Medical (Now Part of Abbott Medical) →