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Argyle Delee Suction Catheter W/Mucous

by Sherwood Medical Co.

510(k) K820572

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820572 Date9 Apr 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KTR
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Argyle DeLee Suction Catheter with Mucous is a Class 2 aspirating tube device. It is designed for suctioning applications, featuring chimney and directional valves for fingertip control.

This device is supplied with a mucus trap and whistle tip, and is available in a 10 French size with a 20 mL capacity. It is authorized for use based on its substantial equivalence determination by the FDA.

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Questions

AI-generated answers, 6 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 Argyle DeLee Suction Catheter with Mucous used for?

    The Argyle DeLee Suction Catheter with Mucous is an aspirating tube device used for suctioning applications. It features chimney and directional valves for fingertip control during use.

  • What accessories are included with the Argyle DeLee Suction Catheter?

    This device is supplied with a mucus trap and a whistle tip, which are components designed to assist in the suctioning process and collection of mucous.

  • What are the available sizes and capacities for this suction catheter?

    The Argyle DeLee Suction Catheter with Mucous is available in a 10 French size and has a 20 mL capacity. This specifies its diameter and the volume it can hold.