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MAMBA and MAMBA Flex Microcatheters

by Boston Scientific 2 variants

510(k) K190401

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK190401 Date15 Mar 2019ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1429-2021 FDA Class II initiated 5 Mar 2021
    • Terminated Z-1430-2021 FDA Class II initiated 5 Mar 2021

    The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

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  • Withdrawn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 Corporation
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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