510(k) Report

FDA applicant

Sentreheart, Inc.

Palo Alto, CA6 decisions2006–20151 recall

FDA records 6 decisions for Sentreheart, Inc. (Palo Alto, CA) from 2006 to 2015: 6 510(k) clearances. Most are in product codes GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) and DQX (Wire, Guide, Catheter). Its devices cite 15 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

FDA’s records also spell it “Sentreheart”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2015

2008: 22009: 12014: 12015: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1, 1 Class I
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sentreheart, 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?

  • GATSuture, Nonabsorbable, Synthetic, Polyethylene4decisions
  • DQXWire, Guide, Catheter1decision
  • DQYCatheter, Percutaneous1decision

Whose devices does it build on?

Its devices cite 15 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K060721Lariat Loop ApplicatorSentreheart · 20062cite it
  • K090385Lariat II Suture Delivery DeviceSentreheart, Inc. · 20091cites it
  • K142241LARIAT sulture Delivery DeviceSentreheart, Inc. · 20141cites it

What has FDA decided for it lately?

  • K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015
  • K142241LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014
  • K090385Lariat II Suture Delivery DeviceSentreheart, Inc. · 2009
  • K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 20081 Class I recall
  • K070126Occlusion Balloon CatheterSentreheart, Inc. · 2008
  • K060721Lariat Loop ApplicatorSentreheart · 2006

All 5 as Sentreheart, Inc. →The one decision as Sentreheart →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080364FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in…Sep 29, 2016Class I