Ndyag Laser Tracheal Tube
FDA 510(k) K880960 · Sheridan Catheter Corp.
510(k) numberK880960
Submission
- Device name
- Ndyag Laser Tracheal Tube
- Applicant
- Sheridan Catheter Corp.
Argyle, NY, US - Received
- March 8, 1988
- Decision date
- April 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5730
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251794 | Tenax® Laser Resistant Endotracheal TubeBTR · Traditional | Bryan Medical, Inc. | 09/03/2026SE |
| K253437 | Spiro-VISTABTR · Traditional | Spiro Robotics | 06/12/2026SE |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal…BTR · Traditional | Covidien, LLC | 10/06/2025SE |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | Covidien, LLC | 09/25/2025SE |
| K243579 | AeroJet Ventilation CatheterBTR · Traditional | Pipeline Medical Products, LLC | 08/13/2025SE |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…BTR · Special | William Cook Europe Aps | 06/11/2025SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | Flexicare Medical Limited. | 05/20/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | Teleflex Medical | 04/29/2025SE |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional | Teleflex Incorporated | 02/11/2025SE |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…BTR · Traditional | Covidien, LLC | 05/20/2024SE |
More from Covidien, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K922894 | Lazer-Trach Tracheal TubeBTR · Traditional | 05/07/1993SE |
| K897046 | Laser Resistant Tracheal TubeCBI · Traditional | 03/23/1990SE |
| K890823 | Accessory to Clinical Electronic ThermometerFLL · Traditional | 05/05/1989SE |
| K884765 | Clinical Electronic ThermometersFLL · Traditional | 02/16/1989SE |
| K882918 | Kim Naso-Intestinal TubeKNT · Traditional | 12/05/1988SE |
| K882127 | Clinical Electronic ThermometersFLL · Traditional | 08/04/1988SE |
| K881368 | Clinical Electonic ThermometersFLL · Traditional | 07/13/1988SE |
| K881293 | Sheridan Electrosurgery Protection FilterBZT · Traditional | 06/16/1988SE |
| K881873 | Introduction/Drainage Catheter & AccessGBS · Traditional | 05/18/1988SE |
| K875226 | Esophageal Obturator/Tracheal TubeCAO · Traditional | 01/19/1988SE |
Questions and answers
When was Ndyag Laser Tracheal Tube cleared by the FDA?
Ndyag Laser Tracheal Tube (K880960) received a 510(k) decision of Substantially Equivalent on April 29, 1988, 52 days after the submission was received.
What is the product code of K880960?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.