Identity
- Trade Name
- MILLER FDA UDI
- Generic Name
- Cardiac septostomy catheter, balloon FDA UDI
- Device Name
- MILLER BALLOON ATRIOSEPTOSTOMY CATHETER FDA UDI
- Model / Reference
- 830515F FDA UDI
- Description
- MILLER BALLOON ATRIOSEPTOSTOMY CATHETER FDA UDI
Identifiers
- Catalog Number
- 830515F FDA UDI
- Primary DI / UDI-DI
- 00690103043778 FDA UDI
- FDA Product Code
- DXF FDA UDI
- GMDN Term
- Cardiac septostomy catheter, balloon FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5175 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac septostomy catheter, balloon
Miller by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac septostomy catheter, balloon.
- Z-5™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
- Z-5™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
- Z-6™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
- Z-6™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
- FOGARTY — Edwards Lifesciences LLC · Class II
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
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI d9112d9b-5f78-4a59-a058-e9c18f118f7e 37 fields · synced Jun 8, 2026