510(k) Report

FDA applicant

Sequent Medical, Inc.

Aliso Viejo, CA4 decisions2013–20171 recall

FDA records 4 decisions for Sequent Medical, Inc. (Aliso Viejo, CA) from 2013 to 2017: 4 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and KRA (Catheter, Continuous Flush). Its devices cite 11 predicates, 4 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 Sequent Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013: 22015: 12017: 1
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2013high 1 (2016) · low 0 (2013)2026

Class I Class II/III not classified

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

Planning a device like Sequent Medical, 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?

  • DQYCatheter, Percutaneous3decisions
  • KRACatheter, Continuous Flush1decision

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 20133cite it
  • K150894VIA 21 MicrocatheterSequent Medical, Inc. · 20152cite it
  • K162565VIA 17 MicrocatheterSequent Medical, Inc. · 20171cites it
  • K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 20131cites it

What has FDA decided for it lately?

  • K162565VIA 17 MicrocatheterSequent Medical, Inc. · 2017
  • K150894VIA 21 MicrocatheterSequent Medical, Inc. · 2015
  • K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 20131 recall
  • K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013

All 4 as Sequent Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K132652VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is…Sep 23, 2016Class II