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Introstat Lead Introducer

by Msi, Inc.

510(k) K960200

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK960200 Date2 Jul 1996ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0254-04 FDA Unclassified (pre-2012) initiated 4 Nov 2003
    • Terminated Z-0256-04 FDA Unclassified (pre-2012) initiated 4 Nov 2003
    • Terminated Z-0255-04 FDA Unclassified (pre-2012) initiated 4 Nov 2003
    • Terminated Z-0257-04 FDA Unclassified (pre-2012) initiated 4 Nov 2003

    The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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