Identity
- Trade Name
- MEDADV FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- ENCOURAGE PTCA BALLOON CATHETER 3.0 mm X 20 mm RAPID EXCHANGE FDA UDI
- Model / Reference
- M92130020 FDA UDI
- Description
- ENCOURAGE PTCA BALLOON CATHETER 3.0 mm X 20 mm RAPID EXCHANGE FDA UDI
Identifiers
- Catalog Number
- M92130020 FDA UDI
- Primary DI / UDI-DI
- 00819667020852 FDA UDI
- 510(k) Number
- K123473 FDA UDI
- FDA Product Code
- LOX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5100 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: Coronary angioplasty balloon catheter, basic
Medadv by Medas, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123473 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 |
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Manufacturer
- Manufacturer
- Medas, Inc.
Sources (1)
- FDA UDI a149c1d3-d178-4a6d-9772-dff9dea88158 37 fields · synced Jun 8, 2026