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Renegade STC 18 Microcatheter

by Boston Scientific

510(k) K023681

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK023681 Date26 Nov 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2244-2009 FDA Unclassified (pre-2012) initiated 26 Aug 2009 on shared 510(k) K023681

    Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DQO
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Renegade STC 18 Microcatheter is a cardiovascular device intended for peripheral vascular use. It is designed to be coaxially tracked over a steerable guidewire to access distal, tortuous vasculature.

The device is supplied in configurations including angled and straight tip shapes with 20 and 30 cm distal tip length options. It is intended for 0.018" coil deployment and has a 1,000 PSI burst pressure rating. The device received FDA 510(k) clearance under K023681 and is classified under product code DQO.

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Questions

AI-generated answers, 1 Oct 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 Renegade STC 18 Microcatheter used for?

    The Renegade STC 18 Microcatheter is intended for peripheral vascular use and is designed to be coaxially tracked over a steerable guidewire to access distal, tortuous vasculature, enabling navigation in complex arterial pathways during interventions.

  • What configurations and specifications does the Renegade STC 18 Microcatheter have?

    The device is supplied in angled and straight tip shapes with 20 cm or 30 cm distal tip length options, is intended for 0.018-inch coil deployment, and has a burst pressure rating of 1,000 PSI, providing flexibility for various procedural needs.

  • How was the Renegade STC 18 Microcatheter cleared for market?

    The Renegade STC 18 Microcatheter received FDA 510(k) clearance under submission number K023681 on November 26, 2002, and was determined to be substantially equivalent to a predicate device, allowing it to be marketed for its intended use.