Ensite 3000 System

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K983456 ↗

FDA Product Code

MTD

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESU

• Enstylet Models EC0010, EC0020

  Class II

  FDA 510(k) K993376 Active Cleared 5 Jan 2000

• Ensite 3000 System

  Class II

  FDA 510(k) K992479 Active Cleared 2 Dec 1999

• Ensite System

  Class II

  FDA 510(k) K033211 Active Cleared 30 Oct 2003

• Ensite 3000 System, Model EE3000

  Class II

  FDA 510(k) K001437 Active Cleared 7 Jun 2000

• Ensite System, Model EE3000

  Class II

  FDA 510(k) K042493 Active Cleared 15 Oct 2004

• Modification to Ensite 3000 System, Model EE3000

  Class II

  FDA 510(k) K012926 Active Cleared 28 Sep 2001

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