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Occlusion Balloon

by Boston Scientific

510(k) K062202

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 · Special NumberK062202 Date20 Oct 2006ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA product code
DQY
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 870.1250
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

An occlusion balloon is a device used to temporarily block blood flow in a vessel. It is designed for cardiovascular applications.

This device is supplied non-sterile and is intended for single use. It has received FDA 510(k) clearance under product code DQY and is manufactured by Boston Scientific Corp.

Other devices from Boston Scientific

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Questions

AI-generated answers, 21 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 occlusion balloon used for?

    The occlusion balloon is used to temporarily block blood flow in a vessel during cardiovascular procedures. It is designed specifically for cardiovascular applications where transient vessel occlusion is needed to support interventions such as angioplasty or stent placement.

  • Is the occlusion balloon sterile when supplied?

    No, the occlusion balloon is supplied non-sterile. This means it must be sterilized by the user or healthcare facility before use, following validated sterilization methods appropriate for the device materials and intended single-use application.

  • Can the occlusion balloon be reused after a procedure?

    No, the occlusion balloon is intended for single use only. Reuse is not recommended due to risks of material degradation, loss of mechanical integrity, or contamination, which could compromise patient safety and device performance.

  • What regulatory pathway was used for this occlusion balloon?

    The occlusion balloon received FDA 510(k) clearance under submission number K062202, demonstrating substantial equivalence to a legally marketed predicate device. It is classified under product code DQY and was reviewed by the Cardiovascular advisory committee.