Skip to content

The Solopath Balloon Expandable Transfemoral Introducer

by Onset Medical Corporation

510(k) K100819

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 · Special NumberK100819 Date2 Aug 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1374-2019 FDA Class I initiated 26 Apr 2019

    There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Onset Medical Corporation

See all devices from Onset Medical Corporation →