510(k) Report

FDA applicant

Xablecath, Inc.

Salt Lake City, UT3 decisions2017–20190 recalls

FDA records 3 decisions for Xablecath, Inc. (Salt Lake City, UT) from 2017 to 2019: 3 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and PDU (Catheter For Crossing Total Occlusions). Its devices cite 3 predicates, 1 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 Xablecath, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017: 12018: 12019: 1
2017high 1 (2017) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Xablecath, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQYCatheter, Percutaneous2decisions
  • PDUCatheter For Crossing Total Occlusions1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K170041XableCath Support CatheterXablecath, Inc. · 20171cites it

What has FDA decided for it lately?

  • K183357XableCath Crossing CatheterXablecath, Inc. · 2019
  • K180986XableCath Support Catheter Product FamilyXablecath, Inc. · 2018
  • K170041XableCath Support CatheterXablecath, Inc. · 2017

All 3 as Xablecath, Inc. →