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Matrix Detachable Coils

by Boston Scientific, Target 510(k)

Active United States

510(k) K012985

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012985 Date31 Jan 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

10 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-0861-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0859-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0856-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0855-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0860-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0862-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0854-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0857-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0863-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)
    • Terminated Z-0858-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 via K012985, on the same 510(k)

    The product appears to have premature degradation of the PGLA coating on the Matrix Coil.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
HCG
Device Class
Class II
Regulation
21 CFR Part 882.5950
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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