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Arrow M.I.S. Multi-Lumen Catheteriza

by Arrow Intl., Inc.

510(k) K820648

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK820648 Date14 Apr 1982ClearedStatusActive

Recalls

7 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2007-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-2009-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-2008-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-2006-2018 FDA Class II initiated 11 Apr 2018

    Product sterility may be compromised due to unsealed packaging.

  • 3 recalls, same reason

    • Terminated Z-2492-2010 FDA Unclassified (pre-2012) initiated 29 Jul 2010
    • Terminated Z-2489-2010 FDA Unclassified (pre-2012) initiated 29 Jul 2010
    • Terminated Z-2490-2010 FDA Unclassified (pre-2012) initiated 29 Jul 2010

    Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle

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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 M.I.S. Multi-Lumen Catheter is a cardiovascular device designed for multi-lumen catheterization procedures. It is a Class 2 medical device classified under product code DQY.

The device was cleared through the FDA 510(k) pathway on April 14, 1982, under K number K820648, and is manufactured by Arrow International, Inc. It is supplied as a reusable or single-use device depending on configuration, though specific sterility, MRI safety, size, storage, and usage settings are not detailed in the provided data.

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Questions

AI-generated answers, 27 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 M.I.S. Multi-Lumen Catheter used for?

    The Arrow M.I.S. Multi-Lumen Catheter is designed for multi-lumen catheterization procedures in cardiovascular applications, as indicated by its classification under product code DQY and its intended use in such clinical settings.

  • How is the Arrow M.I.S. Multi-Lumen Catheter supplied?

    The device is supplied as either a reusable or single-use device depending on its specific configuration, though the exact configurations that determine reuse status are not detailed in the provided data.

  • What regulatory pathway was used to clear the Arrow M.I.S. Multi-Lumen Catheter?

    The device was cleared through the FDA 510(k) pathway on April 14, 1982, under K number K820648, with a decision of substantially equivalent (SESE) to a predicate device.