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Aries 40CC Percu. (D/L) Intra-Aortic Balloon Cath.

by Aries Medical, Inc.

510(k) K882289

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 NumberK882289 Date12 Dec 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  • Withdrawn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
DSY
Device Class
Class II
Regulation
21 CFR Part 870.3450
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 Aries 40cc Percu. (D/L) Intra-Aortic Balloon Cath. is a cardiovascular device classified as a vascular graft prosthesis. It is designed for use in clinical applications within the cardiovascular specialty.

This device is regulated under FDA 510(k) clearance K882289. It is identified by product code DSY and falls under device class 2, adhering to regulation number 870.3450.

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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 primary clinical application for the Aries 40cc Percu. Intra-Aortic Balloon Cath.?

    This device is designed for use in clinical applications within the cardiovascular specialty. It is categorized as a vascular graft prosthesis.

  • What is the regulatory status of this device?

    The device is regulated under FDA 510(k) clearance K882289. It is classified as a class 2 device under regulation number 870.3450 and is identified by product code DSY.

  • Which medical specialty is this device intended for?

    The Aries 40cc Percu. Intra-Aortic Balloon Cath. is intended for use within the cardiovascular specialty, as indicated by its classification and advisory committee designation.