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Opta 5 Modification

by Cordis Corp.

510(k) K933236

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 NumberK933236 Date27 Dec 1993ClearedStatusActive

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  • Withdrawn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)

Full name
Cordis Opta 5(Tm), Modification
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 Opta 5 Modification is a peripheral transluminal angioplasty catheter. It is designed for the dilation of peripheral arteries to improve blood flow, primarily used in the treatment of peripheral arterial disease. This device is classified under the FDA’s product code LIT as a Class II catheter, subject to special controls for safety and performance.

This catheter is intended for single-use in clinical environments such as hospitals and catheterization labs. It is regulated under FDA 510(k) clearance (K933236) and falls under the regulatory designation 870.1250. The device is not MRI-compatible and must be stored and handled per manufacturer instructions to preserve sterility and functionality.

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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 Cordis Opta 5 Modification catheter used for?

    The Cordis Opta 5 Modification is a peripheral transluminal angioplasty catheter specifically designed to dilate peripheral arteries, improving blood flow in patients with peripheral arterial disease. It is intended for use in clinical settings like hospitals and catheterization labs to restore vascular patency.

  • Is the Cordis Opta 5 Modification catheter single-use or reusable?

    This catheter is explicitly designed for single-use only. It must not be reused after a single procedure to maintain sterility and performance. Reuse could compromise safety and regulatory compliance.

  • How should the Cordis Opta 5 Modification catheter be stored?

    The catheter must be stored according to the manufacturer’s instructions to preserve sterility and functionality. It should be kept in its original, sealed packaging until ready for use, away from direct sunlight, extreme temperatures, and contamination sources.

  • Can the Cordis Opta 5 Modification catheter be used with MRI equipment?

    No, the Cordis Opta 5 Modification catheter is not MRI-compatible. It should never be used in or near MRI environments, as this could pose safety risks to both the patient and the device.

  • What regulatory pathway does the Cordis Opta 5 Modification catheter follow?

    The device is regulated under the FDA’s 510(k) clearance pathway, specifically classified under product code LIT as a Class II catheter. It was granted clearance (K933236) in 1993 and falls under regulatory designation 870.1250, with a decision of ‘Substantially Equivalent’ by the Cardiovascular Advisory Committee.