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Constellation Catheters, Model 8031M

by Boston Scientific

510(k) K021232

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Special NumberK021232 Date16 May 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0639-05 FDA Unclassified (pre-2012) initiated 14 Feb 2005

    The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.

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  • Withdrawn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
MTD
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 870.1220
Advisory Committee
Cardiovascular
FDA Decision
SESU

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