Skip to content

H-H Catheter Passers(Tacl Design

by Holter-Hausner Intl.

510(k) K853370

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853370 Date18 Sep 1985ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0160-04 FDA Unclassified (pre-2012) initiated 9 Sep 2003 on shared 510(k) K853370
    • Terminated Z-0161-04 FDA Unclassified (pre-2012) initiated 9 Sep 2003 on shared 510(k) K853370

    mislabeled as sterile

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  • Withdrawn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
GYK
Device Class
Class I
Regulation
21 CFR Part 882.4545
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Holter-Hausner Intl.

See all devices from Holter-Hausner Intl. →