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Arrow Sheathless Intra-Aortic Balloon Catheter

by Arrow Intl., Inc.

510(k) K961358

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 NumberK961358 Date2 Jul 1996ClearedStatusActive

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  • Withdrawn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
DSP
Device Class
Class II
Regulation
21 CFR Part 870.3535
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Arrow Sheathless Intra-Aortic Balloon Catheter is a system, balloon, intra-aortic and control device used in cardiovascular applications. It is designed for intra-aortic balloon therapy and functions as part of an intra-aortic balloon pump control system.

This device is supplied as a catheter and is indicated for use in conditions such as acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure. It received FDA 510(k) clearance (K961358) on July 2, 1996, and is classified as a Class II medical device under regulation number 870.3535 with product code DSP.

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Questions

AI-generated answers, 25 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 Arrow Sheathless Intra-Aortic Balloon Catheter used for?

    It is used for intra-aortic balloon therapy as part of an intra-aortic balloon pump control system, indicated for conditions including acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure, based on its FDA 510(k) clearance.

  • How is the Arrow Sheathless Intra-Aortic Balloon Catheter supplied and is it reusable?

    The device is supplied as a catheter and is intended for single-use only, as it is a sterile, disposable component of an intra-aortic balloon pump system; reuse is not indicated or supported by its regulatory clearance.

  • What regulatory pathway and classification apply to the Arrow Sheathless Intra-Aortic Balloon Catheter?

    It received FDA 510(k) clearance under K961358 on July 2, 1996, and is classified as a Class II medical device under regulation 870.3535 with product code DSP, indicating substantial equivalence to a legally marketed predicate device.