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Angioscopy Pump

by Baxter Healthcare Corp

510(k) K895074

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895074 Date31 Jan 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
DQI
Device class
Class II
Regulation
21 CFR Part 870.1800
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Angioscopy Pump is a Withdrawal/Infusion Pump (Product Code: DQI) designed for controlled fluid management during angiographic procedures. It facilitates precise infusion or withdrawal of contrast media, saline, or other fluids to support diagnostic or interventional angiography, ensuring stable imaging conditions while minimizing patient risk.

This device is intended for use in clinical settings such as cardiac catheterization labs or interventional radiology suites. Supplied as a reusable medical device, it adheres to FDA 510(k) clearance (K895074) under Class II – Special Controls for cardiovascular applications. No specific sterility or MRI safety information is provided in the regulatory data, and its operational parameters (e.g., flow rates, pressure limits) are not detailed beyond its classification as a withdrawal/infusion pump.

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Questions

AI-generated answers, 1 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 Angioscopy Pump used for in clinical settings?

    The Angioscopy Pump is designed for controlled infusion or withdrawal of fluids—such as contrast media or saline—during angiographic procedures. This ensures stable imaging conditions by maintaining consistent fluid dynamics, which is critical for accurate diagnostic or interventional angiography in cardiac catheterization labs or interventional radiology suites.

  • Is the Angioscopy Pump a single-use or reusable device?

    The Angioscopy Pump is supplied as a reusable medical device. Unlike disposable alternatives, it is intended for repeated use in clinical environments, provided it is properly maintained and cleaned between procedures.

  • What regulatory pathway does the Angioscopy Pump follow?

    The Angioscopy Pump is cleared under the FDA’s 510(k) pathway (K895074) as a Class II device under Special Controls for cardiovascular applications. This classification reflects its role in controlled fluid management during angiographic procedures, where precision and safety are paramount.

  • Does the Angioscopy Pump have specific sterility requirements?

    The provided regulatory data does not specify sterility requirements for the Angioscopy Pump. Clinicians should follow standard infection control protocols for reusable medical devices, including cleaning and disinfection between uses, to ensure patient safety.

  • What types of fluids can be managed with the Angioscopy Pump?

    The Angioscopy Pump is intended for managing contrast media, saline, or other compatible fluids during angiographic procedures. Its design supports precise infusion or withdrawal to optimize imaging quality while minimizing risks associated with fluid instability.