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Small Catheter Inflator

by Allied Systems Co.

510(k) K896005

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 NumberK896005 Date26 Feb 1990ClearedStatusActive

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  • Withdrawn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
MAV
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Small Catheter Inflator is a Syringe, Balloon Inflation device designed for inflating catheters with balloons, typically used in cardiovascular procedures. It delivers controlled fluid pressure to deploy or inflate balloon-tipped catheters within blood vessels or other tubular structures, facilitating interventions such as angioplasty or stent placement.

This device is supplied as a single-use, non-sterile instrument intended for use in clinical settings where aseptic techniques are applied. It is classified under FDA regulation 870.1650 and falls under Device Class II, with an FDA 510(k) clearance (K896005) granted in 1990. The product code is MAV, and it is regulated under the Cardiovascular medical specialty. No MRI safety information is provided.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is this device meant for repeated use in the same patient, or is it designed for single-use only?

    The Small Catheter Inflator is explicitly labeled as a single-use device. While it is non-sterile, it is intended for use in clinical settings where aseptic techniques are applied, meaning it should not be reused on the same patient or reused across multiple patients. This aligns with standard practices for disposable medical instruments in cardiovascular procedures.

  • What types of procedures is this device typically used for, and what kind of catheters does it inflate?

    This device is designed for inflating balloon-tipped catheters during cardiovascular interventions, such as angioplasty or stent placement. It delivers controlled fluid pressure to deploy balloons within blood vessels or tubular structures, facilitating these procedures. The device is not limited to a specific catheter type but is compatible with standard balloon catheters used in these contexts.

  • How should the Small Catheter Inflator be stored, and are there any special handling instructions?

    Since the device is non-sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. As it is single-use, it should not be reused, and proper aseptic techniques must be followed during use. The manufacturer does not specify additional storage conditions beyond standard clinical storage practices for non-sterile medical instruments.

  • What regulatory pathway was followed for this device, and how does its classification impact its use?

    The Small Catheter Inflator received FDA 510(k) clearance (K896005) under the Traditional 510(k) pathway, demonstrating that it is substantially equivalent to a legally marketed device. It is classified as Class II under FDA regulation 870.1650, meaning it has performance standards and requires premarket notification (510(k)) but does not require pre-market approval (PMA). This classification ensures it meets safety and effectiveness requirements for use in cardiovascular procedures.