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Aries Peel Away Percutaneous Catheter Introducer

by Aries Medical, Inc.

510(k) K871140

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 NumberK871140 Date22 Apr 1987ClearedStatusActive

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
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 Aries Peel Away Percutaneous Catheter Introducer is a medical device designed to aid in the percutaneous insertion of catheters into blood vessels. It features a peel-away sheath that simplifies the process of catheter placement by allowing the sheath to be removed without dislodging the catheter. This design facilitates stable and precise catheter positioning during clinical procedures.

This device is classified as an introducer, catheter under product code DYB. It received FDA 510(k) clearance on April 22, 1987, under submission number K871140. The device is manufactured by Aries Medical, Inc., located in North Attleboro, Massachusetts.

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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 primary function of the Aries Peel Away Percutaneous Catheter Introducer?

    This device is designed to assist clinicians in the percutaneous insertion of catheters into blood vessels. It utilizes a peel-away sheath mechanism that allows the sheath to be removed after the catheter is positioned, ensuring the catheter remains stable and in place without being dislodged during the procedure.

  • What is the regulatory status of this introducer?

    The Aries Peel Away Percutaneous Catheter Introducer received FDA 510(k) clearance on April 22, 1987, under submission number K871140. It is classified under product code DYB for use in cardiovascular procedures.

  • Who manufactures the Aries Peel Away Percutaneous Catheter Introducer?

    The device is manufactured by Aries Medical, Inc., which is located in North Attleboro, Massachusetts. The company manages the production and regulatory compliance for this specific catheter introducer model.