Identity
- Trade Name
- LIGATURE SLEEVE FDA UDI
- Generic Name
- Endocardial defibrillation lead FDA UDI
- Model / Reference
- 664760-302 FDA UDI
Identifiers
- Catalog Number
- LS21-10 FDA UDI
- Primary DI / UDI-DI
- 20802526563229 FDA UDI
- 510(k) Number
- K020669 FDA UDI
- FDA Product Code
- DTB FDA UDI
- GMDN Term
- Endocardial defibrillation lead FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.3680 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
No
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
Yes
FDA UDI
Category: Endocardial defibrillation lead
Ligature Sleeve by Oscor Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endocardial defibrillation lead.
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- Durata™ — ST. JUDE MEDICAL, INC. · Class III
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Cleared under the same submission
K020669 also covers:
- LS-14 — Oscor Inc.
- LS14B20 — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
- Ligature Sleeve — Oscor Inc.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Oscor Inc.
Sources (1)
- FDA UDI 47f2065c-3626-4b57-b74a-64601447109d 34 fields · synced May 30, 2026