Chocolate PTA Balloon Catheter

FDA UDI

Class II (US FDA UDI)

by Trireme Medical, Llc

Identity

Trade Name: Chocolate PTA Balloon Catheter FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Model / Reference: B FDA UDI

Identifiers

Primary DI / UDI-DI: M874CB1413540020OTW1 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: 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

Chocolate PTA Balloon Catheter by Trireme Medical, Llc — 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
Pacific™ Plus — MEDTRONIC, INC. · Class II
Metacross OTW — KANEKA Corporation · Class IIa
Armada — Abbott Vascular · 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: Trireme Medical, Llc

Sources (1)

FDA UDI 2d440151-d731-4b4b-96a1-b20c65c010be 32 fields · synced Jun 6, 2026