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Bard Peripheral Balloon Dilatation Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910822

by C. R. Bard, Inc.

Identifiers

510(k) Number
K910822 FDA 510(k)
FDA Product Code
LIT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a peripheral balloon dilatation catheter, designed for transluminal angioplasty to mechanically widen narrowed or obstructed blood vessels in the peripheral vascular system. It employs an inflatable balloon to dilate stenotic lesions, improving blood flow through arteries or veins.

The catheter is supplied as a single-use, sterile medical device and is intended for use in interventional radiology or cardiology settings. It is classified as a Class II device under FDA regulations (870.1250) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Multiple reference codes (e.g., K910822) and sizes are available, ensuring compatibility with various vascular procedures.

Frequently asked questions

What is the primary clinical purpose of the BARD Peripheral Balloon Dilatation Catheter, and where is it typically used?

The BARD Peripheral Balloon Dilatation Catheter is designed for transluminal angioplasty, a procedure that mechanically widens narrowed or obstructed blood vessels in the peripheral vascular system. It is specifically intended to dilate stenotic lesions in arteries or veins to improve blood flow. This device is used in interventional radiology or cardiology settings, where precise vascular intervention is required.

Is the BARD Peripheral Balloon Dilatation Catheter intended for single-use or repeated use, and how does this affect its sterility?

The device is explicitly labeled as single-use only, meaning it is not designed for reuse. As a single-use product, it is supplied in a sterile condition to ensure patient safety and prevent contamination during use. Sterility is maintained until the first use, after which it must be discarded.

What types of sizes or models are available for the BARD Peripheral Balloon Dilatation Catheter, and how does this impact procedure selection?

The device comes in multiple sizes and models, as indicated by the extensive list of FDA registration numbers (e.g., K910822) and product codes (LIT). These variations allow clinicians to select the appropriate catheter diameter, length, and balloon profile to match the specific vascular anatomy and lesion characteristics of the patient. This flexibility ensures compatibility with a wide range of peripheral vascular procedures.

How should the BARD Peripheral Balloon Dilatation Catheter be stored, and are there any special handling instructions?

While the exact storage instructions are not detailed in the provided data, single-use, sterile medical devices like this catheter typically require protection from moisture, extreme temperatures, and physical damage. They should be stored in a clean, dry environment as specified in the manufacturer’s accompanying documentation. Always follow the supplier’s guidelines for shelf life and handling to maintain sterility and functionality.

What regulatory pathway was followed for FDA clearance of the BARD Peripheral Balloon Dilatation Catheter, and what does this mean for its use?

The device received FDA 510(k) clearance under the Traditional 510(k) Review pathway, with a decision date of August 29, 1991. This clearance was granted based on a finding of substantial equivalence (SESE) to predicate devices, meaning it was determined to have the same intended use, technological characteristics, and performance as legally marketed competitors. Clinicians can rely on this classification to confirm its compliance with FDA standards for peripheral angioplasty catheters in interventional 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: MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Conquest 40 ..., Bard Peripheral Vascular True Instructions For Use Manual, BARD PERIPHERAL BALLOON DILATATION CATHETER (K942400) — FDA 510(k ..., True™ Dilatation Balloon Valvuloplasty Catheters - BD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K910822 24 fields · synced Sep 19, 2026