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Fibered Platinum Coil, .035 Type

by Target Therapeutics

510(k) K955293

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 NumberK955293 Date6 Feb 1996ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1033-03 FDA Unclassified (pre-2012) initiated 23 Jun 2003 on shared 510(k) K955293
    • Terminated Z-1034-03 FDA Unclassified (pre-2012) initiated 23 Jun 2003 on shared 510(k) K955293

    Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa

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  • Withdrawn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
KRD
Device Class
Class II
Regulation
21 CFR Part 870.3300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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