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Modification for PTA Balloon Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K981906

by Cook, Inc.

Identifiers

510(k) Number
K981906 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 catheter, angioplasty, peripheral, transluminal, as defined by its classification name and intended for use in peripheral vascular interventions. It is a modification of a PTA balloon catheter designed for percutaneous transluminal angioplasty procedures.

It is supplied as a single-use device and has received FDA 510(k) clearance under K981906, with a decision date of June 29, 1998. The device is classified as Class II, product code LIT, and regulation number 870.1250, and is indicated for use in cardiovascular applications per the advisory committee review.

Frequently asked questions

What is the MODIFICATION FOR PTA BALLOON CATHETER used for?

This device is a catheter designed for percutaneous transluminal angioplasty procedures in peripheral vascular interventions, intended to dilate narrowed or blocked arteries in the cardiovascular system as part of angioplasty therapy.

Is the MODIFICATION FOR PTA BALLOON CATHETER reusable or single-use?

The device is supplied as a single-use device, meaning it is intended for one procedure only and should be discarded after use to prevent cross-contamination and ensure patient safety.

How is the MODIFICATION FOR PTA BALLOON CATHETER supplied and sterilized?

The device is supplied sterile and ready for use, packaged to maintain sterility until the point of use, consistent with standard practices for single-use intravascular catheters.

What regulatory pathway was used for the MODIFICATION FOR PTA BALLOON CATHETER?

The device received FDA 510(k) clearance under submission K981906, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under product code LIT.

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: MODIFICATION FOR PTA BALLOON CATHETER (K981906) - FDA 510(k), MODIFICATION FOR PTA BALLOON CATHETER 510 (k) K981906 - FDA.report, Advance® 35LP Low-Profile PTA Balloon Dilatation Catheter - Cook Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cook, Inc.

Sources (1)

  • FDA 510(k) K981906 24 fields · synced Sep 24, 2026