Skip to content

Arterial Anchor Bandage

by Guidelines, Inc.

510(k) K883957

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 NumberK883957 Date18 Oct 1988ClearedStatusActive

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  • Withdrawn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
FMK
Device Class
Class II
Regulation
21 CFR Part 878.4850
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Arterial Anchor Bandage is a medical device designed for securing arterial lines. It is intended to provide stabilization and securement for arterial catheters or lines.

This device is supplied by Guidelines, Inc. and is authorized under FDA 510(k) clearance K883957 with product code FMK. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

Questions

AI-generated answers, 21 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 Arterial Anchor Bandage used for?

    The Arterial Anchor Bandage is a medical device specifically designed for securing arterial lines. It provides stabilization and securement for arterial catheters or lines to ensure proper placement and function.

  • Is the Arterial Anchor Bandage single-use or reusable?

    The device is not specified as single-use or reusable in the provided information. Users should refer to the manufacturer's instructions for specific guidance on usage and disposal.

  • What regulatory authorization does the Arterial Anchor Bandage have?

    The Arterial Anchor Bandage is authorized under FDA 510(k) clearance K883957 with product code FMK. It has been determined to be substantially equivalent to predicate devices.

  • Who manufactures the Arterial Anchor Bandage?

    The Arterial Anchor Bandage is manufactured by Guidelines, Inc., located in Miami, Florida. The company has been producing this device since at least 1988 when it received FDA clearance.