Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula
FDA 510(k) K003315 · Mallinckrodt, Inc.
510(k) numberK003315
Submission
- Device name
- Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula
- Applicant
- Mallinckrodt, Inc.
St. Charles, MO, US - Received
- October 23, 2000
- Decision date
- November 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOH – Tube Tracheostomy And Tube Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5800
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code JOH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with…JOH · Traditional | Covidien, LLC | 12/29/2025SE |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…JOH · Traditional | Smiths Medical Asd, Inc. | 11/26/2021SE |
| K203362 | TRACOE varioJOH · Traditional | Tracoe Medical GmbH | 08/05/2021SE |
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffJOH · Traditional | Covidien | 06/01/2020SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | Cook Incorporated | 12/12/2019SE |
| K182861 | Shiley Neonatal/Pediatric Tracheostomy TubeJOH · Traditional | Covidien | 03/22/2019SE |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…JOH · Traditional | Smiths Medical Asd, Inc. | 05/08/2018SE |
| K180034 | Weinmann Tracheostomy Exchange SetJOH · Traditional | Cook Incorporated | 05/07/2018SE |
| K172720 | TRACOE silcosoft Tracheostomy TubeJOH · Traditional | Tracoe Medical GmbH | 04/27/2018SE |
| K170720 | Portex Blue Line Ultra Paediatric Tracheosomy TubeJOH · Traditional | Smiths Medical Asd, Inc. | 12/07/2017SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003075 | Knightstar 330 VentilatorMNT · Traditional | 12/11/2001ST |
Questions and answers
When was Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula cleared by the FDA?
Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula (K003315) received a 510(k) decision of Substantially Equivalent on November 8, 2000, 16 days after the submission was received.
What is the product code of K003315?
The FDA product code is JOH – Tube Tracheostomy And Tube Cuff, a Class II (moderate risk) device regulated under 21 CFR 868.5800.