Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula

• • Terminated Z-0569-04 FDA Unclassified (pre-2012) ·initiated 12 Dec 2003

  Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm

510(k) Number

K980466 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Csecure Combined Spinal/Epidural Anesthesia System with Lock

  Class II

  FDA 510(k) K993619 Active Cleared 28 Apr 2000

• Wallace Oocyte Retrieval Set-16g, Model MEONS1633; Wallace Oocyte Retrieval Set-17g, Model MEONS1733

  Class II

  FDA 510(k) K000628 Active Cleared 13 Mar 2000

• Sims Portex Epidural Catheter, 20g Model# 4910-16/17; 21g Model# 4910-18

  Class II

  FDA 510(k) K992471 Active Cleared 22 Oct 1999

• Spinal Anesthesia Needles and Introducer Needles

  Class II

  FDA 510(k) K983858 Active Cleared 29 Jan 1999

• Sims Portex Anesthesia Catheter

  Class II

  FDA 510(k) K994275 Active Cleared 22 Feb 2000

• Cpap System, Model 102001

  Class II

  FDA 510(k) K001318 Active Cleared 20 Jul 2000

See all devices from Sims Portex, Inc. →