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Opti-Plast 5F PTA Catheters, Modification

by Vas-Cath, Inc. 3 variants

510(k) K914500

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914500 Date31 Dec 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Opti-Plast 5F PTA Catheters, Modification is a catheter, angioplasty, peripheral, transluminal designed for use in percutaneous transluminal angioplasty (PTA) procedures. These catheters are intended to dilate narrowed or obstructed blood vessels in peripheral arteries, improving blood flow to affected areas. Constructed with a 5 French (5F) lumen size, they are engineered to facilitate precise catheterization and intervention in vascular interventions.

These catheters are supplied as single-use, sterile medical devices and are classified under FDA regulation number 870.1250 as Class II devices. They are intended for use in controlled clinical settings such as catheterization laboratories. The device holds an FDA 510(k) clearance (K914500) under the traditional review pathway, with a decision date of December 31, 1991. No third-party review was required, and the product code assigned is LIT. The device is intended for cardiovascular applications, adhering to regulatory standards for peripheral vascular interventions.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Opti-Plast 5F PTA Catheter used for?

    The Opti-Plast 5F PTA Catheter is designed specifically for percutaneous transluminal angioplasty (PTA) procedures. It is intended to dilate narrowed or obstructed blood vessels in peripheral arteries, thereby restoring or improving blood flow to affected areas. This is particularly useful in treating conditions like peripheral artery disease (PAD) where arterial stenosis limits circulation.

  • How is the Opti-Plast 5F PTA Catheter supplied and what does this mean for use?

    The Opti-Plast 5F PTA Catheter is supplied as a single-use, sterile medical device. This means each catheter is intended for one-time use only and is packaged in a sterile condition to prevent contamination. Clinicians should follow standard sterile technique protocols when handling and using the device to maintain sterility and ensure patient safety.

  • Are these catheters reusable, or is their use limited to a single procedure?

    These catheters are explicitly designed for single-use only. Reusing medical devices like catheters poses significant risks, including infection and device failure, due to potential contamination or degradation of materials. The single-use designation ensures patient safety and compliance with medical device regulations.

  • What size lumen does the Opti-Plast 5F PTA Catheter have, and why is this important?

    The Opti-Plast 5F PTA Catheter features a 5 French (5F) lumen size. The