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Long Sheath or Ls, 70 Cm, Long Sheath or Ls, 80 Cm, Long Sheath or Ls, 90 Cm

by Tni Manufacturing, Inc.

510(k) K152876

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 · Traditional NumberK152876 Date8 Jan 2016ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3281-2018 FDA Class II initiated 2 May 2018

    The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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