510(k) Report

FDA applicant

Pursuit Vascular, Inc.

Maple Grove, MN2 decisions2013–20180 recalls

FDA records 2 decisions for Pursuit Vascular, Inc. (Maple Grove, MN) from 2013 to 2018: 2 510(k) clearances. All are in product code PEH (Hemodialysis Catheter Luer End Cap). Its devices cite 1 predicate, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Pursuit Vascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013: 12018: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Pursuit Vascular, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • PEHHemodialysis Catheter Luer End Cap2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K131060Clearguard HD End CapPursuit Vascular, Inc. · 20131cites it

What has FDA decided for it lately?

  • K180111ClearGuard HD Antimicrobial Barrier CapPursuit Vascular, Inc. · 2018
  • K131060Clearguard HD End CapPursuit Vascular, Inc. · 2013

All 2 as Pursuit Vascular, Inc. →