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Accessor Peripheral Dilating Guide Wire

by Peripheral Systems Group

510(k) K895179

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 NumberK895179 Date28 Feb 1990ClearedStatusActive

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  • Withdrawn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
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
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 Accessor Peripheral Dilating Guide Wire is a percutaneous catheter device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. It is designed for use in peripheral vascular procedures to facilitate access and dilation of blood vessels.

The device is supplied by Peripheral Systems Group and has received FDA 510(k) clearance with the number K895179. It is classified as a Class II medical device under product code LIT and regulation number 870.1250. The device is intended for cardiovascular procedures and is available in various sizes as indicated by the multiple registration numbers associated with this clearance.

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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 Accessor Peripheral Dilating Guide Wire used for?

    The Accessor Peripheral Dilating Guide Wire is a percutaneous catheter device designed for use in peripheral vascular procedures to facilitate access and dilation of blood vessels through the skin using a dilator and a sheath or guide wire.

  • How is the Accessor Peripheral Dilating Guide Wire supplied?

    The device is supplied by Peripheral Systems Group and is available in various sizes as indicated by the multiple registration numbers associated with its FDA 510(k) clearance.

  • What is the regulatory status of the Accessor Peripheral Dilating Guide Wire?

    The device has received FDA 510(k) clearance with number K895179 and is classified as a Class II medical device under product code LIT and regulation number 870.1250.

  • What procedures is the Accessor Peripheral Dilating Guide Wire intended for?

    The device is intended for cardiovascular procedures where access and dilation of blood vessels are required, making it suitable for various peripheral vascular interventions.