Home / 510(k) Clearances / K133597

510(k) K133597

CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY by Cook, Inc. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2014
Date Received
November 22, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Cook, Inc.

  • K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER (January 9, 2015)
  • K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE (December 15, 2014)
  • K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (October 9, 2014)
  • K131772 — CANTATA(R) 2.9 MICROCATHETER (February 20, 2014)
  • K131204 — ADVANCE CS CORONARY SINUS INFUSION CATHETER (January 29, 2014)
  • K133634 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (December 23, 2013)
  • K132020 — ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (October 25, 2013)
  • K131201 — ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GAST (October 7, 2013)
  • K131206 — COOK CERVICAL RIPENING BALLOON (September 27, 2013)
  • K132334 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET (August 16, 2013)

Other clearances for product code JOH

  • K251313 — Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with (December 29, 2025)
  • K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach (November 26, 2021)
  • K203362 — TRACOE vario (August 5, 2021)
  • K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (June 1, 2020)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube (March 22, 2019)
  • K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc (May 8, 2018)
  • K180034 — Weinmann Tracheostomy Exchange Set (May 7, 2018)
  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
  • K170720 — Portex Blue Line Ultra Paediatric Tracheosomy Tube (December 7, 2017)