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Catheter, Cardiovascular, Balloon Type (K883852)

by Wb Intl., Inc.

510(k) K883852

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 NumberK883852 Date7 Dec 1989ClearedStatusActive

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  • Withdrawn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)

Full name
Catheter, Cardiovascular, Balloon Type
510(k) Number
FDA Product Code
DXE
Device Class
Class II
Regulation
21 CFR Part 870.5150
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.

This device is a catheter, cardiovascular, balloon type, designed for use in vascular procedures. It is classified under the Catheter, Embolectomy nomenclature and is intended for mechanical removal of thrombi or emboli within blood vessels, facilitating blood flow restoration in cardiovascular applications.

The catheter is supplied as a single-use, sterile medical device and is regulated under FDA 510(k) clearance (K883852) with a Substantially Equivalent (SESE) determination. It falls under Device Class II (DXE) and adheres to FDA regulation 870.5150, with no third-party review. Storage and handling must comply with standard sterile medical device protocols.

Other devices from Wb Intl., Inc.

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 primary use of this balloon catheter?

    This catheter is designed specifically for mechanical removal of thrombi or emboli within blood vessels. By inflating the balloon, it physically disrupts and clears blockages, restoring blood flow in cardiovascular applications like peripheral arteries or coronary vessels. It is classified under the Catheter, Embolectomy nomenclature, ensuring its intended use aligns with FDA-recognized standards for embolic interventions.

  • Is this device single-use or reusable?

    This device is supplied as a single-use, sterile medical device. Single-use design ensures patient safety by eliminating cross-contamination risks and maintains sterility integrity for one procedure only. Reuse is not recommended or supported by the manufacturer, as it could compromise device performance and regulatory compliance.

  • How should this catheter be stored to maintain sterility?

    Storage must comply with standard sterile medical device protocols. The device should be kept in its original, unopened packaging until immediately before use. Protect it from moisture, extreme temperatures, and physical damage. Once opened, the catheter must be used promptly to preserve sterility, as prolonged exposure to air or handling could compromise its sterile field.

  • What regulatory pathway does this device follow?

    This catheter is regulated under the FDA 510(k) clearance pathway with a Substantially Equivalent (SESE) determination (K883852). It falls under Device Class II (DXE) and adheres to FDA regulation 870.5150, which governs embolic protection and vascular devices. The clearance was granted by the Cardiovascular (CV) Advisory Committee, ensuring its safety and effectiveness for mechanical thrombus removal.

  • Are there multiple sizes or models available for this catheter?

    The provided data does not specify individual sizes or models beyond the general classification as a balloon-type embolectomy catheter. However, the OpenFDA registration lists multiple FEI numbers (e.g., 1000138054, 3005747797), which may correspond to variations in catheter diameter, length, or balloon profile. For precise sizing details, refer to the manufacturer’s technical documentation or consult Wb Intl., Inc. directly, as these variations are critical for procedural success.