Mega Angiogram Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K913397 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SEKD

• Mega Arthrogram Kit

  Class II

  FDA 510(k) K913317 Active Cleared 31 Oct 1991

• Mega Continuous Epidural Anesthesia Kit

  Class II

  FDA 510(k) K912445 Active Cleared 18 Oct 1991

• Mega Pericardiocentesis Kit

  Class II

  FDA 510(k) K912564 Active Cleared 5 Sep 1991

• Mega Paracentesis Kit

  Class II

  FDA 510(k) K913382 Active Cleared 8 Oct 1991

• Mega Amniocentesis Kit

  Class I

  FDA 510(k) K915863 Active Cleared 30 Mar 1992

• Mega Spinal Anesthesia Kit

  Class II

  FDA 510(k) K912322 Active Cleared 26 Sep 1991