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Peripherally Inserted Medline Catheter

by Arrow Intl., Inc.

510(k) K963257

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK963257 Date4 Mar 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2385-2018 FDA Class II initiated 17 May 2018

    Product pouch label may not easily identify the lot number, expiration date and associated symbols..

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  • Withdrawn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
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
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 Peripherally Inserted Medline Catheter is a long-term intravascular catheter (greater than 30 days) designed for therapeutic use. It is classified as a Class II medical device under FDA regulations and is intended for venous access, providing a reliable conduit for infusion therapy. Constructed from medical-grade polyurethane, the catheter is engineered to minimize vessel trauma and maintain patency over extended periods.

This catheter is supplied in single or double lumen configurations, with trimmable or non-trimmable lengths, and may include an optional placement wire. It is intended for clinician-operated insertion and is typically used in general hospital settings. The device is single-use and requires sterile handling; regulatory clearance (FDA 510K) confirms its compliance with safety and performance standards for long-term venous access applications.

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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 Medline Peripherally Inserted Catheter used for?

    The Medline Peripherally Inserted Catheter is designed for long-term venous access (greater than 30 days) to provide a stable conduit for infusion therapy. Its polyurethane construction reduces vessel trauma, making it suitable for extended clinical use in general hospital settings.

  • How is the catheter supplied, and what configurations are available?

    The catheter is supplied in single or double lumen versions, with options for trimmable or non-trimmable lengths. Some models may also include an optional placement wire to assist with insertion. These variations allow clinicians to select the best fit for patient needs.

  • Is the Medline Peripherally Inserted Catheter single-use or reusable?

    This catheter is intended for single-use only. It requires sterile handling to ensure patient safety and compliance with medical device standards, as outlined in its FDA 510K clearance.

  • What materials is the catheter made from, and why does it matter?

    The catheter is constructed from medical-grade polyurethane, a durable yet flexible material chosen to minimize vessel trauma during prolonged use. This material also helps maintain catheter patency over extended periods, reducing the risk of occlusion or complications.

  • How should the catheter be stored before use?

    The catheter must be stored in a sterile, sealed packaging until use. Proper storage ensures sterility and prevents contamination, which is critical for single-use medical devices like this catheter. Always follow manufacturer guidelines for unpacking and handling.