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Ant Inflation Device Compact Pack

by Shenzhen Ant Hi-Tech Industrial Co., Ltd.

510(k) K102648

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 NumberK102648 Date1 Jul 2011ClearedStatusActive

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  • Withdrawn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)

Full name
Ant Inflation Device/Ant Inflation Device Compact Pack
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 Ant Inflation Device Compact Pack is a Syringe, Balloon Inflation, designed for inflating and deflating balloon catheters in cardiovascular procedures. It provides precise control over inflation pressure, ensuring accurate deployment and retrieval of intravascular balloons during angioplasty or other interventional radiology applications.

This device is supplied as a single-use, sterile, Class II medical product, regulated under FDA 510(k) clearance (K102648) and classified under regulation 870.1650. It is intended for use in controlled clinical settings, such as catheterization labs, and must be stored according to manufacturer instructions to maintain sterility and functionality. No MRI safety information is specified.

Other devices from Shenzhen Ant Hi-Tech Industrial Co., Ltd.

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.

  • What is the primary use of the Ant Inflation Device Compact Pack in clinical settings?

    The Ant Inflation Device Compact Pack is specifically designed for inflating and deflating balloon catheters during cardiovascular procedures, such as angioplasty or interventional radiology. It provides precise control over inflation pressure to ensure accurate deployment and retrieval of intravascular balloons in controlled settings like catheterization labs.

  • Is the Ant Inflation Device Compact Pack intended for single-use or reusable applications?

    The device is explicitly labeled as a single-use product. This classification ensures sterility and safety for each procedure, preventing cross-contamination between patients.

  • How should the Ant Inflation Device Compact Pack be stored to maintain its integrity?

    The device must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Since it is sterile and single-use, it should be kept in its original packaging, protected from moisture, physical damage, and extreme temperatures until use.

  • What regulatory pathway does the Ant Inflation Device Compact Pack follow, and what classification does it hold?

    The device is regulated under FDA 510(k) clearance (K102648) and classified as a Class II medical product under regulation 870.1650. It was determined to be substantially equivalent to a predicate device and reviewed by the Cardiovascular (CV) Advisory Committee.

  • Are there any known compatibility concerns with MRI equipment for this device?

    The manufacturer does not specify MRI safety information for the Ant Inflation Device Compact Pack. Clinicians should verify compatibility with their MRI systems before use in an MRI environment, as standard assumptions about MRI safety may not apply.