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Sign in to claim this brandSENTREHEART, INC
US
Last updated May 24, 2026
Information
- Country
- US
- Address
- —
- Website
- sentreheart.com
- —
- —
- [email protected]
- Phone
- 1-855-256-7330
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 068810802
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lariat | RS | FDA UDI | Class I | Active |
| FindrWIRZ | 4005 | FDA UDI | Class II | Active |
| Lariat | III | FDA UDI | Class I | Unknown |
| Tensure | 7 lb | FDA UDI | Class I | Active |
| SofTIP | Long | FDA UDI | Class II | Active |
| SureCUT | 5001 | FDA UDI | Class I | Active |
| EndoCATH | 2006 | FDA UDI | Class II | Active |
| LARIAT RS Suture Delivery Device | K153096 | FDA 510(k) | Class II | Active |
| Lariat Loop Applicator | K060721 | FDA 510(k) | Class II | Active |
| Occlusion Balloon Catheter | K070126 | FDA 510(k) | Class II | Active |
| Findrwirz Guide Wire System | K080364 | FDA 510(k) | Class II | Active |
| Lariat Ii Suture Delivery Device | K090385 | FDA 510(k) | Class II | Active |
| LARIAT sulture Delivery Device | K142241 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 29, 2016 | Z-0328-2017 | — | terminated | 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. |