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Maxforce Biliary Dilatation Catheter and Hurricane Rx Biliary Catheter

by Boston Scientific

510(k) K130484

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

9 ongoing

This device is named in the recall

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 NumberK130484 Date9 Aug 2013ClearedStatusActive

Recalls

9 recalls · 9 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-0324-2022 FDA Class II initiated 21 Oct 2021
    • Ongoing Z-0321-2022 FDA Class II initiated 21 Oct 2021
    • Ongoing Z-0325-2022 FDA Class II initiated 21 Oct 2021
    • Ongoing Z-0320-2022 FDA Class II initiated 21 Oct 2021
    • Ongoing Z-0323-2022 FDA Class II initiated 21 Oct 2021
    • Ongoing Z-0322-2022 FDA Class II initiated 21 Oct 2021
    • Ongoing Z-0327-2022 FDA Class II initiated 21 Oct 2021
    • Ongoing Z-0326-2022 FDA Class II initiated 21 Oct 2021

    Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

    • Ongoing Z-0286-2021 FDA Class II initiated 16 Sep 2020

    RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

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  • Withdrawn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
FGE
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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