Angiojet Solent Omni Thrombectomy Set

• • Terminated Z-2378-2015 FDA Class II ·initiated 31 Jul 2015 ·on shared 510(k) K111182

  AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K111182 ↗

FDA Product Code

QEZ

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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