510(k) Report

FDA applicant

St. Jude Medical, Daig Division, Inc.

Minnetonka, MN2 decisions2005–20051 recall

FDA records 2 decisions for St. Jude Medical, Daig Division, Inc. (Minnetonka, MN) in 2005: 2 510(k) clearances. All are in product code DYB (Introducer, Catheter). Its devices cite 2 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 St. Jude Medical, Daig Division, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for St. Jude Medical, Daig Division, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — St. Jude Medical, Daig Division, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like St. Jude Medical, Daig Division, Inc.’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

Which product codes does it file in?

  • DYBIntroducer, Catheter2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042623Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 20054cite it

What has FDA decided for it lately?

  • K051096Apeel CS Plus Catheter Delivery System, Models 407579, 407580, 407581, 407582St. Jude Medical, Daig Division, Inc. · 2005
  • K042623Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 20051 recall

All 2 as St. Jude Medical, Daig Division, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042623St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia).…Apr 14, 2006