Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

• • Terminated Z-1486-2021 FDA Class II ·initiated 19 Mar 2021

  On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.

510(k) Number

K162181 ↗

FDA Product Code

DRE

Device Class

Class II

Regulation

21 CFR Part 870.1310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Cardiacassist, Inc. →