Armada

FDA UDI

Class II (US FDA UDI)

by Abbott Vascular

Identity

Trade Name: Armada FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: Armada 35 PTA Catheter 12 mm x 40 mm x 135 cm / Over-The-Wire FDA UDI
Model / Reference: B2120-040 FDA UDI
Description: Armada 35 PTA Catheter 12 mm x 40 mm x 135 cm / Over-The-Wire FDA UDI

Identifiers

Catalog Number: B2120-040 FDA UDI
Primary DI / UDI-DI: 08717648155550 FDA UDI
FDA Product Code: LIT FDA UDI
DQY 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

Armada is a high-quality peripheral angioplasty balloon catheter designed for minimally invasive procedures, offering flexibility and durability in percutaneous transluminal angioplasty (PTA) applications. This sterile, non-drug-eluting tube features an over-the-wire or rapid exchange design, making it suitable for various patient needs. Developed by Abbott Vascular Inc., Armada is a single-use device available in specific catalog numbers and product codes.

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
Advocate™ — Merit Medical Systems, Inc. · Class II
Senri — KANEKA Corporation · Class IIa
Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
Pacific™ Plus — MEDTRONIC, INC. · Class II
Metacross OTW — KANEKA Corporation · Class IIa
RapidCross — Covidien LP · 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

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Manufacturer

Manufacturer: Abbott Vascular

Sources (1)

FDA UDI 0ac21e24-a76e-40cd-baaa-a36e6de66c50 36 fields · synced Jul 25, 2026