Septisleeve

• • Terminated Z-0295-2020 FDA Class II ·initiated 16 Oct 2018 ·on shared 510(k) K820883

  The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

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

510(k) Number

K820883 ↗

FDA Product Code

DYG

Device Class

Class II

Regulation

21 CFR Part 870.1240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• V-Stick Vascular Access Set

  Class II

  FDA 510(k) K130730 Active Cleared 22 Nov 2013

• Digicath

  Class II

  FDA 510(k) K831171 Active Cleared 25 May 1983

• Central Catheter Kit

  Class II

  FDA 510(k) K780673 Active Cleared 16 May 1978

• Argon Dual Lumen Hemodialysis, Catheter

  Class II

  FDA 510(k) K842039 Active Cleared 29 Jan 1985

• Translumbar Aortography Needle Catheter

  Class II

  FDA 510(k) K884375 Active Cleared 11 Jan 1989

• Introducer for Ptca Guiding Catheters

  Class II

  FDA 510(k) K891022 Active Cleared 19 May 1989

See all devices from Argon Medical Corp. →