Trek

FDA UDI

Class II (US FDA UDI)

by Abbott Vascular

Identity

Trade Name: TREK FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: TREK Coronary Dilatation Catheter 4.00 mm x 15 mm / Over-The-Wire FDA UDI
Model / Reference: 1012411-15 FDA UDI
Description: TREK Coronary Dilatation Catheter 4.00 mm x 15 mm / Over-The-Wire FDA UDI

Identifiers

Catalog Number: 1012411-15 FDA UDI
Primary DI / UDI-DI: 08717648154409 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Coronary angioplasty balloon catheter, basic

The TREK Coronary Dilatation Catheter is a flexible, over-the-wire catheter designed for percutaneous transluminal coronary angioplasty (PTCA). This single-use device features a unique design with multiple lumen options and is intended for the dilation of narrowed or obstructed coronary arteries. The TREK Coronary Dilatation Catheter is sterile, has an expiration date, and may be labeled as No Radiation-Contrast Imaging (NRL) by regulatory agencies such as FDA. It also meets certain storage requirements and is available in various sizes for implantation or pre/after-dilatation.

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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 a34a5ada-054a-4a54-a911-2536ac3746e1 36 fields · synced Jun 23, 2026