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Reprocessed Cs Bi-Diectional Diagnostic Electrophysiology Catheter

by Ascent Healthcare Solutions

510(k) K100254

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

26 ongoing

This device is named in the recall

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)SESE Substantially Equivalent · Traditional NumberK100254 Date28 May 2010ClearedStatusActive

Recalls

27 recalls · 26 ongoing · FDA

  • 26 recalls, same reason

    • Ongoing Z-2177-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2174-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2191-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2181-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2187-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2195-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2176-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2192-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2198-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2185-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2183-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2194-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2188-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2199-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2189-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2180-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2186-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2190-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2179-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2184-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2196-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2197-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2193-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2178-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2175-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2182-2026 FDA Class II initiated 10 Apr 2026

    Incomplete seals on sterile product

    • Terminated Z-2426-2018 FDA Class II initiated 29 Mar 2018

    Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .

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
NLH
Device Class
Class II
Regulation
21 CFR Part 870.1220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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