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Viatrac 14 Plus Peripheral Dilation Catheter

by Abbott Vascular-Vascular Solutions

510(k) K072798

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 NumberK072798 Date31 Jan 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1178-2010 FDA Unclassified (pre-2012) initiated 6 May 2009

    Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.

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  • Withdrawn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

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