Sentreheart, Inc.
Palo Alto, CA, US
Sentreheart, Inc. appears in FDA device records in Palo Alto, CA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Sentreheart, Inc. between 2006 and 2015. The busiest year on record is 2008, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K153096 | LARIAT RS Suture Delivery Device | GAT | Substantially Equivalent | |
| K142241 | LARIAT sulture Delivery Device | GAT | Substantially Equivalent | |
| K090385 | LARIAT II SUTURE DELIVERY DEVICE | GAT | Substantially Equivalent | |
| K080364 | FINDRWIRZ GUIDE WIRE SYSTEM | DQX | Substantially Equivalent | |
| K070126 | OCCLUSION BALLOON CATHETER | DQY | Substantially Equivalent | |
| K060721 | LARIAT LOOP APPLICATOR | GAT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0328-2017 | FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures. | A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain