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Berman Angiographic Balloon Catheter

by Ziehm International, Inc. 510(k)

Active United States

510(k) K822033

Overview

The Berman Angiographic Balloon Catheter is a diagnostic catheter designed for angiographic procedures, specifically pulmonary angiography and Balloon Occlusion Femoral Angiography (BOFA). It features a balloon component for occlusion and multiple side holes to facilitate high-flow dye injection, aiding in contrast visualization of blood vessels while minimizing complications such as arrhythmias or myocardial staining.

This device is supplied as a single-use, non-sterile catheter intended for use in interventional radiology settings. It is regulated under the FDA’s 510(k) pathway with a clearance number K822033, classified under product code DQO. The catheter is intended for use with compatible angiographic systems and requires proper sterilization and handling prior to patient use, adhering to standard medical device protocols.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822033 Date24 Aug 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Berman Angiographic Balloon Catheter used for?

    The Berman Angiographic Balloon Catheter is specifically designed for angiographic procedures, including pulmonary angiography and Balloon Occlusion Femoral Angiography (BOFA). Its balloon component allows controlled occlusion of blood vessels, while multiple side holes enable high-flow dye injection. This design improves contrast visualization of blood vessels while minimizing risks such as arrhythmias or myocardial staining.

  • Is the Berman Angiographic Balloon Catheter single-use or reusable?

    The Berman Angiographic Balloon Catheter is supplied as a single-use device. This ensures patient safety by preventing cross-contamination and maintains device performance for one procedure only, adhering to standard medical device protocols.

  • How should the Berman Angiographic Balloon Catheter be prepared for use?

    The catheter is supplied in a non-sterile state, so it must be sterilized and handled according to standard medical device protocols prior to patient use. Proper sterilization is critical to ensure safety and efficacy during angiographic procedures.

  • What regulatory pathway does the Berman Angiographic Balloon Catheter follow?

    The Berman Angiographic Balloon Catheter is cleared under the FDA’s 510(k) pathway with clearance number K822033. It was determined to be substantially equivalent to a predicate device and reviewed by the Cardiovascular Advisory Committee.

  • Can this catheter be used with any angiographic system?

    The Berman Angiographic Balloon Catheter is intended for use with compatible angiographic systems. Compatibility ensures optimal performance, including proper balloon inflation, dye injection, and visualization during procedures. Always verify system compatibility before use.