Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list SentreHeart with 6 510(k) clearances and 1 device recall. The most recent is a device recall dated Sep 29, 2016: FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use….
| Sep 29, 2016 | FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and Class I · A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE | Device recalls |
| Nov 25, 2015 | LARIAT RS Suture Delivery DeviceK153096 · GAT | 510(k) clearances |
| Sep 12, 2014 | LARIAT sulture Delivery DeviceK142241 · GAT | 510(k) clearances |
| May 6, 2009 | LARIAT II SUTURE DELIVERY DEVICEK090385 · GAT | 510(k) clearances |
| Aug 11, 2008 | FINDRWIRZ GUIDE WIRE SYSTEMK080364 · DQX | 510(k) clearances |
| Feb 8, 2008 | OCCLUSION BALLOON CATHETERK070126 · DQY | 510(k) clearances |
| Jun 2, 2006 | LARIAT LOOP APPLICATORK060721 · GAT | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
