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Renegade Fiber Braided Microcatheter

by Boston Scientific

510(k) K973645

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 · Traditional NumberK973645 Date19 Nov 1997ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0358-2011 FDA Unclassified (pre-2012) initiated 24 Aug 2009

    Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.

    • Terminated Z-0177-2007 FDA Unclassified (pre-2012) initiated 13 Oct 2006

    Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)

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  • Withdrawn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
KRA
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 870.1210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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