Sealguard Evac Endotracheal and Endotracheal Tubes

• 2 recalls, same reason

  • Terminated Z-1626-2016 FDA Class II ·initiated 4 Apr 2016
  • Terminated Z-1625-2016 FDA Class II ·initiated 4 Apr 2016

  Device packaging may not be sealed.

510(k) Number

K082520 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Percutaneous Transluminal Angioplasty Catheter

  Class II

  FDA 510(k) K905773 Active Cleared 30 Jan 1991

• Softouch Guiding Catheter

  Class II

  FDA 510(k) K905547 Active Cleared 5 Feb 1991

• Mallard Medical Model 2400 Anesthesia Ventilator

  Class II

  FDA 510(k) K902405 Active Cleared 4 Mar 1991

• Hygrobac, S Hygroboy and Hygrobaby Open recall

  Class II

  FDA 510(k) K941381 Active Cleared 15 Apr 1994

• Softtouch(R) Guiding Catheter

  Class II

  FDA 510(k) K912199 Active Cleared 30 Jul 1991

• Hygrolife

  Class I

  FDA 510(k) K942794 Active Cleared 22 Aug 1994

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