510(k) Report

FDA applicant

Transaortic Medical, Inc.

Morgan Hill, CA2 decisions2016–20191 recall

FDA records 2 decisions for Transaortic Medical, Inc. (Morgan Hill, CA) from 2016 to 2019: 2 510(k) clearances. All are in product code DYB (Introducer, Catheter). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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 Transaortic Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2016: 12019: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1, 1 Class I
2016high 1 (2020) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Transaortic Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYBIntroducer, Catheter2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152194transGlide Expandable IntroducerTransaortic Medical, Inc. · 20161cites it

What has FDA decided for it lately?

  • K181817transGlideXT Expandable IntroducerTransaortic Medical, Inc. · 20191 Class I recall
  • K152194transGlide Expandable IntroducerTransaortic Medical, Inc. · 2016

All 2 as Transaortic Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K181817Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or…May 12, 2020Class I