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Powerflex Pro Percutaneous Transluminal Angioplasty (PTA) Catheter

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 4400804S510(k) K112797

by Cordis US Corp.

Identity

Trade Name
POWERFLEX™ PRO Percutaneous Transluminal Angioplasty (PTA) Catheter EUDAMED
POWERFLEX FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name
Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter - POWERFLEX™ PRO EUDAMED
POWERFLEXPRO 8MM4CM 80 FDA UDI
Model / Reference
4400804S EUDAMEDFDA UDI
Description
POWERFLEXPRO 8MM4CM 80 FDA UDI

Identifiers

Catalog Number
4400804S FDA UDI
Primary DI / UDI-DI
20705032059814 EUDAMEDFDA UDI
Basic UDI-DI
07050320000000000000024CF EUDAMED
510(k) Number
K112797 FDA UDI
FDA Product Code
LIT FDA UDI
EMDN Code
C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
GMDN Term
Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

The Powerflex Pro Percutaneous Transluminal Angioplasty (PTA) Catheter is a balloon dilatation catheter designed for vascular intervention. Classified under nomenclature code C010402020101, it is intended for dilating stenotic lesions in peripheral arteries, including ilio-femoral, femoro-popliteal, and arteriovenous dialysis fistulae. The device features a distal inflatable balloon and a tapered tip, optimized for compatibility with 0.035-inch guide wires and catheter sheath introducers.

This single-use, sterile device is supplied in a ready-to-use configuration and is intended for use in clinical settings such as catheterization labs or interventional radiology suites. Radiopaque marker bands aid in precise balloon placement, and the catheter is non-implantable, non-reusable, and non-latex. Authorized under FDA 510K and MDR, it adheres to Class IIa regulatory standards with a UDI reference of 4400804S. Storage and handling follow standard sterile medical device protocols.

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

Frequently asked questions

What types of vascular blockages is the Powerflex Pro PTA Catheter designed to treat, and how does its design support this use?

The Powerflex Pro PTA Catheter is specifically designed to dilate stenotic lesions in peripheral arteries, including ilio-femoral, femoro-popliteal regions, and arteriovenous dialysis fistulae. Its tapered tip and distal inflatable balloon are optimized for compatibility with 0.035-inch guide wires and catheter sheath introducers, allowing precise placement and effective dilation of narrowed vessels in these areas. The radiopaque marker bands further assist in accurate balloon positioning during the procedure.

Is the Powerflex Pro PTA Catheter reusable, and if not, how should it be handled to maintain sterility before use?

No, the Powerflex Pro PTA Catheter is a single-use, non-reusable device. It is supplied in a sterile, ready-to-use configuration, so it must be handled using standard sterile medical device protocols. This includes maintaining the sterile packaging until immediately before use and following manufacturer guidelines for opening and preparing the device in a controlled clinical environment like a catheterization lab or interventional radiology suite.

What guide wire and sheath compatibility does the Powerflex Pro PTA Catheter support, and why is this important for clinicians?

The Powerflex Pro PTA Catheter is designed to be compatible with 0.035-inch guide wires and catheter sheath introducers, which is critical for clinicians as it ensures seamless integration with existing interventional tools. This compatibility allows for smoother navigation through the vascular system, reducing the risk of complications during the dilation procedure and improving procedural efficiency.

How should the Powerflex Pro PTA Catheter be stored, and what precautions should be taken to ensure its integrity?

The Powerflex Pro PTA Catheter should be stored following standard sterile medical device protocols. Since it is a single-use, sterile device, it must remain in its original packaging until ready for use to prevent contamination. Storage should be in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve its sterility and functionality until deployment in a clinical setting.

What regulatory pathways has the Powerflex Pro PTA Catheter undergone, and what does this mean for its use in clinical practice?

The Powerflex Pro PTA Catheter has been authorized under both the FDA 510K pathway and the EU Medical Device Regulation (MDR), adhering to Class IIa regulatory standards. This means it has undergone rigorous evaluation to ensure safety and effectiveness for its intended use in dilating peripheral arterial lesions. Clinicians can rely on its regulatory clearance as evidence of its compliance with established medical device standards before use in procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: POWERFLEX Pro PTA Dilatation Catheter - Cordis, POWERFLEX Pro 0.035" PTA Catheter - Cordis, Powerflex Pro Percutaneous Transluminal Angioplasty Catheter, Powerflex Pro Percutaneous Transluminal Angioplasty Catheter

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Cordis US Corp.
EUDAMED SRN
US-MF-000020031
FDA Applicant
Cordis Corp.
Authorised Representative
Cordis Cashel IE-AR-000017793

Sources (3)

  • EUDAMED dceb327f-939e-41ea-9e23-46b5eb3bc2fa 85 fields · synced Sep 19, 2026
  • FDA UDI 78314218-d71b-4b8a-8e1f-2db0de8e7db6 36 fields · synced May 30, 2026
  • FDA 510(k) K112797 1 fields · synced May 18, 2026