Identity
- Trade Name
- ADMIRAL XTREME FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- CATH ADM050200130 ADM US 05 00L200UL1300 FDA UDI
- Model / Reference
- ADM050200130 FDA UDI
- Description
- CATH ADM050200130 ADM US 05 00L200UL1300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033477057545 FDA UDI
- 510(k) Number
- K100921 FDA UDI
- FDA Product Code
- LIT FDA UDIDQY FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 200.0 Millimeter FDA UDIOuter Diameter — 5.0 Millimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
Admiral Xtreme by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
- RapidCross — Covidien LP · Class II
Cleared under the same submission
K100921 also covers:
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, INC.
- ADMIRAL XTREME — MEDTRONIC, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 40e4e533-1a93-4345-b027-b0877e51ff28 37 fields · synced Jun 8, 2026