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Arrow Epidural Catheter Kit

by Teleflexmedical, Inc. 2 variants

510(k) K143581

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 NumberK143581 Date26 Jun 2015ClearedStatusActive

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  • Withdrawn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
CAZ
Device Class
Class II
Regulation
21 CFR Part 868.5140
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Arrow Epidural Catheter Kit is an anesthesia conduction kit used for epidural procedures. It includes components for administering epidural anesthesia, featuring a bullet-tip epidural needle designed to deflect upon contact with the dura.

The kit is supplied by Teleflex Medical, Inc. and is a Class II device cleared by the FDA under 510(k) K143581. It is intended for single use in clinical settings under the supervision of qualified medical professionals.

Other devices from Teleflex Medical, LLC

See all devices from Teleflex Medical, LLC →

Questions

AI-generated answers, 26 Sep 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 Arrow Epidural Catheter Kit used for?

    The Arrow Epidural Catheter Kit is an anesthesia conduction kit specifically designed for epidural procedures. It includes components for administering epidural anesthesia, featuring a bullet-tip epidural needle that deflects upon contact with the dura.

  • Is the Arrow Epidural Catheter Kit reusable or single-use?

    The Arrow Epidural Catheter Kit is intended for single use only. It should be used once in clinical settings under the supervision of qualified medical professionals and then discarded according to medical waste disposal protocols.

  • What regulatory approvals does the Arrow Epidural Catheter Kit have?

    The Arrow Epidural Catheter Kit is a Class II device cleared by the FDA under 510(k) K143581. It has been determined to be substantially equivalent to other legally marketed anesthesia conduction kits.

  • What components are included in the Arrow Epidural Catheter Kit?

    The Arrow Epidural Catheter Kit includes all necessary components for administering epidural anesthesia, with its distinctive feature being a bullet-tip epidural needle designed to deflect upon contact with the dura, enhancing safety during epidural procedures.