Accessories & Connectors, 22mm-15mm-8.5mm

• 2 recalls, same reason

  • Terminated Z-0785-2020 FDA Class II ·initiated 7 Aug 2019
  • Terminated Z-0784-2020 FDA Class II ·initiated 7 Aug 2019

  The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

510(k) Number

K911425 ↗

FDA Product Code

BZA

Device Class

Class I

Regulation

21 CFR Part 868.5810

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Manometer

  Class II

  FDA 510(k) K122077 Active Cleared 10 Jan 2013

• Disposable Gas Sampling Line with and Without in-Line Filter

  Class II

  FDA 510(k) K122075 Active Cleared 20 Dec 2012

• Clear-Therm 3 Hmef, Clear-Therm 3 with Superset Catheter Mount, Clear-Therm with Flexible Catheter Mount, Clear-Guard 3 F3

  Class II

  FDA 510(k) K024270 Active Cleared 24 Jun 2003

• Flo-Guard Breathing Filter

  Class II

  FDA 510(k) K121026 Active Cleared 2 Nov 2012

• Clear-Guard Midi, Clear-Guard Midi W/Flextube, Clear-Therm Mini, Clear-Therm Mini W/Flextube, Models 1644, 1644-T, 1831, 18

  Class II

  FDA 510(k) K983610 Active Cleared 30 Apr 1999

• Intersurgical Inter-Therm Breathing Filter and Heat and Moisture Exchanger, Intersurgical Inter-Guard Breathing Filter

  Class II

  FDA 510(k) K092451 Active Cleared 29 Oct 2010

See all devices from Intersurgical, Inc. →