Identity
- Trade Name
- Lariat FDA UDI
- Generic Name
- Open-surgery ligature loop FDA UDI
- Device Name
- Suture Delivery Device FDA UDI
- Model / Reference
- RS FDA UDI
- Description
- Suture Delivery Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- M95530060 FDA UDI
- 510(k) Number
- K153096 FDA UDI
- FDA Product Code
- HCF FDA UDIGAT FDA UDI
- GMDN Term
- Open-surgery ligature loop FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI878.5000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Open-surgery ligature loop
Lariat by Sentreheart, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K153096 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sentreheart, Inc
Sources (1)
- FDA UDI 743f3091-e5a7-4bbb-9a2f-fa0068e6fb11 35 fields · synced Jun 8, 2026