Identity
- Trade Name
- HELIOS FDA UDI
- Generic Name
- Atrial cardioversion system catheter FDA UDI
- Model / Reference
- H05RH110U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885672001520 FDA UDI
- 510(k) Number
- K072770 FDA UDI
- FDA Product Code
- LDF FDA UDI
- GMDN Term
- Atrial cardioversion system catheter FDA UDI
Classification
- Device Class
- Class II 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
No
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
Yes
FDA UDI
Category: Atrial cardioversion system catheter
Helios by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atrial cardioversion system catheter.
- HELIOS — Oscor Inc. · Class II
- HELIOS — Oscor Inc. · Class II
- HELIOS — Oscor Inc. · Class II
- HELIOS — Oscor Inc. · Class II
- HELIOS — Oscor Inc. · Class II
- HELIOS — Oscor Inc. · Class II
- HELIOS — Oscor Inc. · Class II
Cleared under the same submission
K072770 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oscor Inc.
Sources (1)
- FDA UDI b86f0e09-45f3-42a1-96bf-a0682230225a 34 fields · synced Jun 8, 2026