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Admiral Xtreme

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
ADMIRAL XTREME FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name
Cath ADM080020130 ADM US 08.00L20 UL1300 FDA UDI
Model / Reference
ADM080020130 FDA UDI
Description
Cath ADM080020130 ADM US 08.00L20 UL1300 FDA UDI

Identifiers

Primary DI / UDI-DI
08033477053899 FDA UDI
510(k) Number
K062809 FDA UDI
FDA Product Code
LIT 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
Not 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
Outer Diameter — 8.0 Millimeter FDA UDI
Length — 20.0 Millimeter FDA UDI

Admiral Xtreme by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K062809 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 22b423d5-c92b-4195-bb17-9848d244f9b8 38 fields · synced May 31, 2026