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Acunav Diagnostic Ultrasound Catheter

by Acuson Corp.

510(k) K992631

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 NumberK992631 Date15 Dec 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1745-2011 FDA Unclassified (pre-2012) initiated 20 Mar 2009

    Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.

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  • Withdrawn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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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